Federal Food Drug Research Articles

A Review of the Toxicity of Ingredients in e-Cigarettes, Including Those Ingredients Having the FDA's "Generally Recognized as Safe (GRAS)" Regulatory Status for Use in Food.

Some firms and marketers of electronic cigarettes (e-cigarettes; a type of electronic nicotine delivery system (ENDS)) and refill liquids (e-liquids) have made claims about the safety of ingredients used in their products based on the term "GRAS or Generally Recognized As Safe" (GRAS). However, GRAS is a provision within the definition of a food additive under section 201(s) (21 U.S.C. 321(s)) of the U.S. Federal Food Drug and Cosmetic Act (FD&C Act). Food additives and GRAS substances are by the FD&C Act definition intended for use in food, thus safety is based on oral consumption; the term GRAS cannot serve as an indicator of the toxicity of e-cigarette ingredients when aerosolized and inhaled (ie, vaped). There is no legal or scientific support for labeling e-cigarette product ingredients as "GRAS." This review discusses our concerns with the GRAS provision being applied to e-cigarette products and provides examples of chemical compounds that have been used as food ingredients but have been shown to lead to adverse health effects when inhaled. The review provides scientific insight into the toxicological evaluation of e-liquid ingredients and their aerosols to help determine the potential respiratory risks associated with their use in e-cigarettes.

FDA preemption of conflicting state drug regulation and the looming battle over abortion medications.

Over the past 25 years, Congress and the FDA have determined the safest and most beneficial way to regulate the use of mifepristone (Mifeprex), the medication that accounts for the majority of abortions in the United States. The Dobbs decision has renewed the importance of those scientific determinations, especially FDA's decisions implementing the Risk Evaluation and Mitigation Strategy (REMS) provisions of the Federal Food Drug and Cosmetic Act (FDCA), that mifepristone may be taken by patients outside the presence of any healthcare provider (often through telemedicine prescription and shipment across state lines). Now that Dobbs has been decided, state officials have indicated that they will seek to enforce state statutes which conflict with FDA's regimen for the proper use of mifepristone, by banning its use entirely, prohibiting telemedicine prescription, or imposing other requirements which FDA has specifically considered and now rejected as contrary to the congressional mandate that FDA-approved drugs be as accessible as safety considerations allow. Litigation has already been filed to invalidate such statutes on the grounds that they are preempted by the doctrine that state law which conflicts with, or undermines the purposes of, FDA actions with respect to approved drugs are preempted under the Supremacy Clause of the Constitution. This article examines the Supreme Court caselaw and FDA actions which will dictate the outcome of that litigation. Part I details the statutory basis for FDA preemption of conflicting state law and the four decisions by the Supreme Court over the last 13 years (Levine, Mensing, Bartlett and Albrecht) which enunciate the governing legal standards for FDA preemption. We pay particular attention to the opinions of Justice Alito and the other conservative justices, which hold that such FDA preemption should be robust to ensure that there is one consistent, national policy for the distribution and regulation of drugs, under the science-based decisions of the FDA, rather than the 'parochialism' of differing state standards. Part II details FDA's comprehensive program for the balanced, though appropriately restricted, use of mifepristone, and the 22 years of FDA actions that brought that about. It then catalogs the state statutes limiting the use of the drug which, in material ways, conflict with those FDA determinations. Part III outlines the arguments made in one early lawsuit seeking preemption of the statutes of one state (Mississippi)-a law suit which previews the wider litigation to come. It then sets forth the strong arguments for FDA preemption of each type of state restriction and responses to the 'defenses' of those statutes that have been offered in an effort to avoid FDA preemption under the Supremacy Clause. That review shows that a straight-forward application of the FDCA and the Supreme Court caselaw should result in the preemption of the state restrictions that squarely conflict with the relatively free access to abortion medications which FDA has mandated.

Regulatory considerations for emergency use authorizations of medical products U/s 564 of the federal food drug and cosmetic act, usa

The United States (US) remains the greatest medical device (MD) market on earth $156 billion (40 percent of the overall MD market in 2017). By 2023, it is depended upon to create to $208 billion. As per USFDA, the MD are orchestrated into three classifications. The U.S. Food and Drug Administration's and Center for Devices and Radiological Health (CDRH) supervises MD advertised in the United States. The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a group of laws passed by Congress in 1938 offering power to the U.S. Food and Drug organization (FDA) to administer the safety of food, drugs, cosmetic products and MD’s. An Emergency Use Authorization (EUA) under Section 564 of the FD&C Act considers the unique utilization of medications and other clinical products during particular kinds of crises. This review articles focused the process of EUA of medical products u/s 564 of the Federal Food Drug and Cosmetic Act, USA.

Aace/ace Position Statement on the use of follow-on Biologics and Biosimilars for Endocrine Diseases

BPCIA = Biologics Price Competition and Innovation Act; FDA = Food and Drug Administration; FFDC = Federal Food Drug and Cosmetics Act; PHS = Public Health Services Act; TE = therapeutic equivalence.

Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.

BackgroundCustomizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient’s surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place.PurposeThe objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol.MethodsAn institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013–2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval.ResultsThe average patient age was 12 years old (7–21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7–21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7–19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act’s expanded access provisions.ConclusionsEstablishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated process of obtaining customizable orthopaedic implants for orthopaedic oncology patients.Level of evidenceRetrospective case series, Level IV. See the Guidelines for authors for a complete description of levels of evidence.

Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation.

The integrity of unbiased clinical data is essential to the future of the health care system by facilitating the discovery of lifesaving medicines and ensuring investigational drugs are safe and effective. Since 2002, the US pharmaceutical industry has invested over $500 billion, which is the largest research and development investment of any sector of the US economy. As a consequence of this significant investment, pharmacy compounders and other stakeholders must be acutely aware of the consequences of noncompliance. Pharmacy compounders are required to navigate through a complex and ever-changing regulatory landscape governed by US federal and state authorities competing for oversight and enforcement authority. In particular, pharmacy compounders participating in clinical investigation are faced with inconsistent federal and state drug labeling regulations, which can lead to enforcement for violating acceptable standards for clinical investigation and informed consent. As FDA registrants, Outsourcing Facilities are able to produce large volumes of clinical supplies without the need for prescriptions for individually named patients. Some states, however, may have prescription drug labeling laws that could thwart the ability to provide these clinical supplies. Accordingly, researchers should be aware of the implications of federal and state laws, including any inconsistencies, prior to engaging in clinical investigation.

Phosphate removal from phosphorus containing waste water by coagulation/flocculation process using Gossypium spp. (GS) as coagulant

Phosphate removal from phosphorus containing effluent was carried out using bio-coagulant. Gossypium Spp (cotton seed) an eco- friendly biomass was used as a coagulant in this work for the wastewater treatment through Nephelometric method. The study evaluates the coagulation/flocculation efficiency of GS. Parameters such as pH levels of the effluent, dosages of GS and settling time were varied. Statistical (via 2 3 Central Composite Design, CCD) modeling for process optimization was carried out. The results obtained showed that, maximum coagulation performance E(%) >70 was obtained at 500mg/l GS concentration and pH=6.The most significant main effect for performance of GS as a coagulant is its dosage (Pvalue=0.0006) while pH (Pvalue=0.2070) is the least significant. Keyword:Phosphate;Coagulation/Flocculation; Biomass; Gossypium Spp.; Phosphorus; Effluent I. INTRODUCTION Coagulation and flocculation provide the water treatment process by which finely divided suspended and colloidal matter in the water is made to agglomerate and form flocs. This enables their removal in subsequent sedimentation and filtration stages.(1).Coag-flocculation of wastewater may be accomplished with any of the common water coagulants including lime, iron and aluminum salts and synthetic polymers. However, the search for a better alternative to conventional coagulants has become an important challenge in the water treatment process with the aim of minimizing the detrimental effects associated with the use of such coagulants. The use of coagulants of biological origin has become essential. Some of the coagulants and flocculants of biological origin that have been used include chitosan (2) tannins (3) , aqueous extract of the seed of Moringa Oleifera (4), extracts of Okra, nirmali seed(5) and cotton seed (Gosspium Spp) which is the subject of the study. Cotton is currently the leading plant fibre crop worldwide and is grown commercially in the temperate and tropical regions of more than fifty countries (6) Cotton is primarily grown as fibre crop. It is harvested as 'seed cotton' which is then 'ginned' to separate the seed and lint. The delinted cotton seed can be processed to produce oil, meal and hulls. Oil produced from the seeds has achieved GRAS (Generally Recognized As Safe) status under the United States Federal Food Drug and Cosmetic Act (7). They are also used as a viscosity enhancer (thickener) in ice cream, salad dressing and tooth paste (8).

Suitability of polystyrene as a functional barrier layer in coloured food contact materials

Functional barriers in food contact materials (FCMs) are used to prevent or reduce migration from inner layers in multilayer structures to food. The effectiveness of functional barrier layers was investigated in coloured polystyrene (PS) bowls due to their intended condition of use with hot liquids such as soups or stew. Migration experiments were performed over a 10-day period using USFDA-recommended food simulants (10% ethanol, 50% ethanol, corn oil and Miglyol) along with several other food oils. At the end of the 10 days, solvent dyes had migrated from the PS bowls at 12, 1 and 31 000 ng cm–2 into coconut oil, palm kernel oil and Miglyol respectively, and in coconut oil and Miglyol the colour change was visible to the human eye. Scanning electron microscope (SEM) images revealed that the functional barrier was no longer intact for the bowls exposed to coconut oil, palm kernel oil, Miglyol, 10% ethanol, 50% ethanol and goat’s milk. Additional tests showed that 1-dodecanol, a lauryl alcohol derived from palm kernel oil and coconut oil, was present in the PS bowls at an average concentration of 11 mg kg–1. This compound is likely to have been used as a dispersing agent for the solvent dye and aided the migration of the solvent dye from the PS bowl into the food simulant. The solvent dye was not found in the 10% ethanol, 50% ethanol and goat’s milk food simulants above their respective limits of detection, which is likely to be due to its insolubility in aqueous solutions. A disrupted barrier layer is of concern because if there are unregulated materials in the inner layers of the laminate, they may migrate to food, and therefore be considered unapproved food additives resulting in the food being deemed adulterated under the Federal Food Drug and Cosmetic Act.

Enhancing youth tobacco surveillance to inform tobacco product regulation: findings from the 2012 National Youth Tobacco Survey.

Decreasing youth tobacco use is a significant public health priority. In the U.S., nearly one in 15 middle school students and one in four high school students were current tobacco users in 2012,1 and 5.6 million youth aged under 18 years today are projected to die prematurely from smoking-related disease.2 The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed into law on June 22, 2009, amended the Federal Food Drug and Cosmetic Act (FD&C Act) to provide the U.S. Food and Drug Administration (FDA) with the authority to regulate the manufacturing, distribution, and marketing of tobacco products to protect public health.

Author response to the letter: On “Validity and reliability of the Nintendo Wii Balance Board for assessment of standing balance”: Are the conclusions stated by the authors justified?

[1] Wii Balance Board. [internet]. Wikipedia; 2012 [updated 2012 Nov 26; cited 2013 Feb 15]. Available from: http://en.wikipedia.org/wiki/Wii Balance Board. [2] Lee J, Koh D, Ong CN. Statistical evaluation of agreement between two methods for measuring a quantitative variable. Comput Biol Med 1989;19(1): 61–70. [3] US Federal Food Drug & Cosmetic (FD&C) Act (21 U.S.C. § 301 et seq). [4] Council of the European Communities. Council Directive of 14th June 1993 concerning medical devices. 93/42/EEC. 2007. [5] Council of the European Communities. Directive of the European Parliament and of the Council of 5th September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices andDirective 98/8/EC concerning the placing of biocidal prodcuts on the market. 2007/47/EC. 2007. [6] Australia Therapeutic Goods Act 1989, 41BD. [7] Canada Food and Drugs Act (R.S.C., 1985, c. F-27).

Pediatric medical devices: a look at significant US legislation to address unmet needs

There are many barriers to the availability of medical devices intended for the pediatric population causing healthcare providers to use creative measures to address pediatric unmet device needs. The USA has taken significant legislative measures to spur medical device development and address the unmet needs in all pediatric subpopulations. For example, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food Drug and Cosmetic Act by adding new provisions intended to promote the development of safe and effective pediatric devices, and to protect the pediatric population during clinical trials. In 2004, the Medical Devices Technical Corrections Act was added to address potential difficulties in bringing pediatric devices to the market. Further, the Pediatric Medical Device Safety and Improvement Act of 2007 and the Food and Drug Administration Amendments Act of 2007 provided the FDA significant new responsibilities and authorities regarding pediatric use.

Commercial Speech and Off-Label Drug Uses: What Role for Wide Acceptance, General Recognition and Research Incentives?

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures. Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide "truthful information" to doctors about "widely accepted" off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to "widely accepted" uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks. A health law academic pointed out in an article examining a fraud and abuse case that off-label use of drugs is common, and that practitioners may lack adequate dosage information about the off-label uses. Drug companies may obtain approval of a drug for a narrow use, such as for a specific type of pain, but practitioners use the drug for similar uses based on their experience. The writer maintained that a controlled study may not be necessary to establish efficacy for an expanded use of a drug for pain. Even if this is the case, as discussed below in this paper, added safety risks may exist if the expansion covers a longer period of time and use by a wider number of patients. The protections for commercial speech should not be extended to allow manufacturers to distribute information about practitioner use with a disclosure about the lack of FDA approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies. The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.

Pesticides: Carbofuran under Review

In the 31 July 2008 Federal Register, the Environmental Protection Agency (EPA) published a proposal to revoke all food “tolerances” of the insecticide carbofuran—residue allowances that are allowed to appear on food—on both domestic and imported produce, based on excessive risks to children and wildlife. If approved, this reversal of a July 2006 decision to allow carbofuran tolerances on imported coffee, bananas, sugarcane, and rice would sidestep the need for all-out cancellation of the pesticide’s registration. Carbofuran (trade name Furadan) is a restricted-use pesticide registered in the United States since 1969. The compound causes overstimulation of the nervous system by inhibiting acetyl-cholinesterase. Symptoms of overexposure in humans include headache, weakness, abdominal cramping, nausea, blurred vision, convulsion, tremor, and coma. Carbofuran is highly toxic to birds, fish, and bees. The proposal to revoke tolerances was necessary to protect children, says agency spokesperson Dale Kemery, because “studies have consistently shown that juvenile rats are more sensitive to carbo-furan than adult rats.” Based on EPA risk assessments, children up to age 5 also “experience the highest levels of dietary risk because they tend to eat larger amounts of food per their body weight than do teenagers or adults and because their systems for detoxifying contaminants are still developing.” That assessment was overly conservative, argues John Cummings, regulatory manager for North America at the Agricultural Products Group of FMC Corporation, the sole U.S. manufacturer of carbo-furan. Cummings says the EPA’s risk calculation includes the use of three safety factors, whereas FMC argues that the toxicologic data support a value of 100× for the combination of these factors but not the 400× asserted by the EPA. The three safety factors include a 10× interspecies factor used to extrapolate from animal data to humans, a 10× intraspecies factor used to account for possible variations between individuals, and a 4× uncertainty factor that is permissible under the Food Quality Protection Act. The EPA is only reacting to the law, Kemery says: “We are required by section 408 of the Federal Food Drug and Cosmetic Act to take into account the potential for children to be more sensitive in establishing safe levels on food—for example, by including additional safety factors in our calculations.” The American Bird Conservancy, which has fought for several years to have carbo-furan banned, points out that as far back as 1980 EPA scientists had estimated that over a million birds were killed each year by the granular formulation of carbofuran, the registration for which was cancelled in 1994. Beyond the tolerance revocation, the EPA embarked years ago on an effort to ban all U.S. sales of carbofuran by cancelling its registration altogether on the basis of dietary, occupational, and environmental considerations. This larger move has gotten support from several environmental groups. Alternatively, several U.S. grower groups and the U.S. Department of Agriculture have asked the EPA to consider alternatives to cancellation, claiming carbofuran is economically important to U.S. agriculture. About 1 million pounds are used annually on fruit and vegetable crops including corn, cotton, potatoes, sunflowers, and tobacco. If, following the 29 September 2008 deadline for comments on the proposed action, the EPA issues a final tolerance revocation, FMC could request a hearing. If the revocation becomes law, it would become illegal to sell domestic or imported food bearing any residue of carbo-furan; enforcement would be the responsibility of the Food and Drug Administration.

Pharmacy Is a Science-based Profession

Pharmacy Is a Science-based Profession

Federal Food Drug and Cosmetic Act

Courts may order disgorgement of profits under the Federal Food Drug and Cosmetic Act-United v. Depot, Inc.1 -The United Court of Appeals for the Tenth Circuit reversed a District Court order denying disgorgement as an available remedy under the Federal Food, Drug and Cosmetic Act (FDCA).2 The Tenth Circuit found that courts can order disgorgement because the FDCA invokes general equity jurisdiction and does not contain a legislative or a and inescapable inference prohibiting courts from ordering disgorgement.3 Defendants Depot, Inc., of Canada, LLC, Carl Moore, and David Peoples (collectively Rx Depot) helped United customers obtain reduced-priced prescription drugs from Canada.4 Customers gave Depot information about their prescriptions from American physicians.5 Depot then transmitted this information to cooperating Canadian pharmacies.6 Once Canadian physicians rewrote the American prescriptions, Canadian pharmacies filled these prescriptions and sent them directly to customers in the United States.7 The United filed suit against Depot asserting that Depot violated select provisions of the FDCA by reimporting prescription drugs originally manufactured in the United States and introducing new drugs into interstate commerce without approval.8 The parties subsequently agreed to a consent decree of permanent injunction which confirmed that Depot violated the FDCA and prevented Depot from resuming business operations.9 The consent decree, however, stated that the district court should determine what, if any, equitable relief to award the United States.10 The district court denied restitution because Depot's customers did not lose money when they purchased medications at reduced prices.11 Although the district court initially approved disgorgement of profits as an appropriate remedy, it later determined that the FDCA does not enable courts to order disgorgement.12 The district court found that the FDCA does not permit disgorgement because its legislative history and express allowance of other remedies support a and inescapable inference that Congress did not intend to permit courts to order disgorgement.13 The United appealed the district court's finding that disgorgement is not available under the FDCA.14 The Tenth Circuit analyzed whether the FDCA permits courts to order disgorgement.15 In Porter v. Warner Holding Co., the Supreme Court examined whether the Emergency Price Control Act of 1942 (EPCA) permits courts to order restitution.16 The Supreme Court stated that when a statute invokes equity jurisdiction, courts may use all equitable powers available to exercise that jurisdiction unless the statute restricts the form of equitable relief by clear and valid legislative command or necessary and inescapable inference.17 The Supreme Court considered (1) whether the EPCA expressly or impliedly precluded restitution as a remedy; (2) the strength of the public interest in the suit; and (3) the broad language of the EPCA authorizing courts to provide any . . . other order.18 The Supreme Court later determined that a statute does not have to include the broad language present in the EPCA to permit a court to use its equity powers once the statute grants courts general equity jurisdiction.19 Depot and amicus asserted that Meghrig v. KFC Western, Inc. controls whether the FDCA permits courts to order disgorgement.20 The Supreme Court in Meghrig found that although the Resource Conservation and Recovery Act (RCRA) grants general equity jurisdiction, courts cannot order restitution under the RCRA.2143 The RCRA does not authorize courts to order restitution because the RCRA contains a legislative that precludes restitution and Congress did not intend for the RCRA to permit courts to order restitution.22 The Supreme Court concluded that the language of the RCRA precluded restitution because it was directed only at harm in the immediate future. …

State Regulation of Canadian Pharmacies: A Prescription to Violate the Supremacy Clause

“This Constitution, and the Laws of the United States … shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.”Under the Supremacy Clause of the United States Constitution, federal law, such as the Federal Food Drug and Cosmetic Act (“FDCA”), is supposed to be the “supreme Law of the Land.” The FDCA establishes a national closed domestic distribution system for approved prescription drugs in an effort to ensure drug integrity and safety. In doing so, it purportedly sets the “gold standard” for prescription drugs regulation around the world. Lately, though, this “gold standard” has been tarnished by personal importation, the practice of buying prescription drugs directly from foreign pharmacies—primarily Canadian—in conflict with the FDCA's restrictions on unapproved drugs and importation.

FDA Marketing Claims, and the Practitioner

The Food and Drug Administration (FDA) is the federal agency that is tasked with regulating market entry for medical devices. The laws that govern this process are codified in the Federal Food Drug and Cosmetic Act (the Act) and the regulations are based on this law. The medical device amendments to the Act were instituted in 1976, instituting the methods for classification of medical devices and the format for the premarket review of devices. Information for practitioners on how medical devices come to market, what data are required, how specific claims are cleared, and how the practitioner can give input to the system are critical for the further development of safe and effective medical devices.

Regulatory aspects of invasive glucose measurements.

On May 26, 1976, the Food and Drug Administration (FDA) began implementing the Medical Device Amendments to the Federal Food Drug and Cosmetic Act. These amendments give FDA specific authority to regulate "medical devices." Additional authority was provided in the Safe Medical Devices Act of 1990. The pathways to get in vitro diagnostic products to market for commercial distribution include: premarket notification [or 510(k)] and premarket approval (PMA). Reviews of these applications are performed in the Division of Clinical Laboratory Devices, Office of Device Evaluation within the Center for Devices and Radiological Health. Most submissions for invasive glucose devices are 510(k) applications. Through this process the manufacturer demonstrates that its device is substantially equivalent to another device that is already legally marketed, referred to as the predicate device. To date, noninvasive and minimally invasive glucose testings have been approved through the PMA process and will be discussed in a separate article.

Regulatory initiatives for natural latex allergy: US perspectives

The US Food and Drug Administration (FDA) has regulatory authority over foods, human drugs, cosmetics, medical devices, radiological products, biologics, and veterinary products. Among these products, FDA believes that the use of medical devices, including medical gloves, condoms, catheters, and breathing bags, represents the greatest source of natural latex proteins to exposed individuals. A medical device is defined in the Federal Food Drug and Cosmetic Act (FFDCA) as an instrument, apparatus, implement, machine, etc., that is intended for use in the diagnosis or treatment of disease or is intended to affect the structure or any function of the body of a human or other animal, and that does not achieve any of its principal intended purposes through chemical action in the body. This article provides some brief, general background about FDA's medical device regulatory process and then addresses the issue of natural latex allergy. Finally we discuss the steps the Agency has taken to evaluate the magnitude and nature of the problem, and FDA's efforts to assist manufacturers, health professionals, and others in minimizing exposure and sensitization to natural latex proteins in medical devices.

Current Regulations and Practices for Adverse Event Reporting: Implications for Labeling

Safety reporting and postmarketing surveillance is one of the most important responsibilities of a manufacturer following approval of a new drug. New drug products are approved and placed on the market in the United States under the Federal Food Drug and Cosmetic (FD&C) Act. The FD&C Act allows for the approval of drugs that are safe and effective as determined by appropriate experts, qualified by training and experience to make such determinations. Following approval, the sponsor of each drug product is required to collect, monitor, and report to the Food and Drug Administration on all significant new developments with the drug product, including but not limited to, adverse drug experiences received by the company regarding the product. The collection, review, reporting, and assessment of this safety experience information has a great impact on the labeling for a product and the information provided to practitioners on a continuing basis regarding the safe use of a product. Thus, new safety information a...