Delays In Approval Research Articles

Target Approval Delays Cost Air Force Key Hits

This case study is taken from the early phase of the current war against terrorism in Afghanistan. It exemplifies the complexities of contemporary warfare, in which the commander must weigh the military advantages provided by advanced technology against political, legal and ethical considerations. This can cause frustration in the lower echelons, when it is perceived that opportunities for decisive strikes are missed because of hesitation in the chain of command at higher levels. Following the case study, three commentators examine the military, constitutional and ethical issues raised by this report.

'Target Approval Delays Cost Air Force Key Hits'

'Target Approval Delays Cost Air Force Key Hits'

'Target Approval Delays Cost Air Force Key Hits': Law, Policy, Ethics and the Warfighter's Dilemma

'Target Approval Delays Cost Air Force Key Hits': Law, Policy, Ethics and the Warfighter's Dilemma

Competitors co-operating: establishing a supply chain to manage genetically modified canola

Identity preserving production and marketing (IPPM) systems are used extensively in the Canadian canola industry to segregate varieties with different traits from the commodity stream. This paper examines one use of identify preserved production and marketing systems for genetically modified (GM) canola. A number of transgenic herbicide tolerant (HT) varieties have been approved for release in Canada since 1995 but delays in approval in other countries led the Canadian canola sector to use IPPM systems to segregate these varieties and direct them toward accepted markets. This paper looks at a number of systems developed for input-trait GM canola, with a focus on the governance mechanisms used.

Water pressure: irrigation, governance and land use intensification in Maungatapere, New Zealand

This paper considers the ways in which state-supported proposals for an irrigation scheme contributed to reorienting land use and community dynamics in Maungatapere, a semi-rural locality in Northland, New Zealand. This scheme was first proposed in the early 1980s — a time when key preoccupations of the state included protecting primary industry and promoting land-based production. Soon after, however, such intervention was seriously challenged by free-market philosophies, and state ownership and maintenance of irrigation schemes gave way to user pays and privatisation. At Maungatapere, these changes resulted in delays in approval for the irrigation scheme, a reduction in its area, and the eventual development of an infrastructure which was rapidly sold to private interests. We draw on historical evidence and 1997 survey data to explore land-owner decision-making and perceptions. Our analysis incorporates contemporary concerns for land use intensification, governance and community sustainability. We interpret the irrigation scheme as always having been an object of governance, from its initial conception as a community scheme in the context of assisted agriculture, through to its subsequent metamorphosis into a proprietary scheme reflecting a more market-oriented government vision. We conclude that a focus on one specific place offers insights into the processes whereby policy is translated into practices.

2000 EXPLORATION REVIEW

The level of exploration and appraisal activity in 2000 maintained a level similar to that of the previous year. Drilling activity offshore increased slightly from 1999, maintaining the gradual increase from a low in 1991.Onshore drilling activity also increased slightly, but is still markedly down on expected levels; new permits are not being awarded due to native title issues. Onshore and offshore basins showed a continuing decline in 2D seismic acquisition, but a continuing increase in 3D acquisition. The gradual increase in drilling activity over the past 10 years is, in part, attributed to increased density of drilling in areas that have had 3D seismic coverage.The offshore activity continues to be focussed in the Carnarvon Basin, in which 73% of the wells were located, including perhaps the most significant discovery, Laverda –1, drilled by Woodside. A campaign of 25 wells by the Apache-led JV resulted in three potentially commercial discoveries: Corvus–1, Linda–1 and Tanami–4 (renamed the Simpson field).Overall success rates were high, but this is not translating to commercial reserve additions because of the number of sub-economic oil accumulations and a predominance of gas rather than oil.Onshore a further round of acreage was released in the Cooper/Eromanga Basin, and a surge of activity is expected over the next two to three years. However, award of blocks is being held up by delays in approvals related to native title, which is a major issue for the onshore industry.The new EPBC Act has created significant uncertainty in the industry, with respect to how it is being implemented. It has already led to significant delays in operations and therefore execution of committed work programs.

Telecommunications Regulation and New Services: a Case Study at the State Level ¤

This study introduces methodology to quantify the effects that regulation has on the innovation and the introduction of new products, and compares state-regulated services in Indiana under rate of return regulation (RoRR) and under alternative regulation. The econometric model comprises a count process (for innovation) followed by a duration process with selection (for regulatory delay). When the firm is released from RoRR, the rate of service creation triples and expected approval delays nearly disappear. The firm may have introduced up to 12 times as many services to consumers if the alternative regulation had been in place the entire time.

The Candidates' Views on Science

D uring each of the past several U.S. presidential elections, Science has posed questions about science policy to the major-party candidates. The editors have tried to ask hard questions that challenge the candidates and their staffs to develop thoughtful answers—responses that will not only help Science 's readership evaluate their positions before the election but might clarify important science and technology issues for a much larger number of thoughtful Americans. This year, as in the past, the candidates have been good enough to cooperate fully with Science , and the results provide some significant insights about how the next president might deal with the multiple aspects of U.S. national interest that have scientific and technical roots. We won't insult your intelligence by rehashing or evaluating the responses, the full texts of which are available in a side-by-side outlay beginning on page [262][1] as well as on Science Online. But here are a few areas that, in the view of the editors, are worth highlighting. Our first question was the shortest: It asked Vice President Gore and Governor Bush simply to choose their top three science and technology priorities. Both mentioned education, with Bush—consistent with his major campaign theme—putting it in first place. Gore emphasized investment incentives for research and made major commitments to balance and scope in the federal RD both unveiled programs to assist students with higher education. In responding to some of the later questions, the candidates took fairly similar policy positions. Both, for example, expressed support for raising the ceiling on H1-B visas for foreign high-tech workers, but both put it forward as an interim rather than a permanent solution. And when asked about making presidential appointments in the science and technology area, both candidates promised efforts to speed the process while identifying delays in Senate approval as offering challenges to a successful outcome. Both opposed “reasonable pricing” clauses regarding drugs developed with the help of federal funding. But there were important differences. When queried about the proposal to double the National Science Foundation's budget over the next 5 years, Vice President Gore responded with a clear commitment, whereas Governor Bush promised an unspecified increase. With respect to the deployment of antiballistic missiles, Gore insists on ensuring compliance with the Anti-Ballistic Missile Treaty, whereas Bush proposes to change the treaty terms through negotiated agreements with Russia. Gore likes the space station; Bush would reevaluate it. Gore liked the Advanced Technology Program at the National Institute of Standards and Technology; Bush didn't say, but advocated more support for defense-related research. Perhaps it is not surprising that the starkest differences are over programs and policies that have themselves been the subject of especially intense national controversy. Affirmative action programs are clearly favored by Vice President Gore; Governor Bush proposes “affirmative access”: expanded recruitment efforts without preference. Our question on the scientific evidence regarding the human imprint on global warming drew an affirmation from Gore that might have been predicted from his previously announced position. But the answer from Bush emphasized other atmospheric quality issues. On global warming, he described the temperature increase as a slight one with uncertain causes, and advocated “extensive scientific analysis” to explore the issue further. Science has not endorsed candidates for partisan elective office in the past, and we don't intend to start now. Those of our readers who are eligible to vote in the United States, most of them practicing scientists, will want to evaluate the evidence and then reach their own conclusions. We also know that in making their choice, they are unlikely to limit their evaluation of the candidates to issues that lie in the domain of science policy. Still, the future of the United States is perhaps more dependent than ever on science and technology and on how the U.S. government supports and manages them. These issues are our business here at Science . We hope that our readers will compare the candidates' responses carefully and that they will find them useful on November 7. [1]: /lookup/doi/10.1126/science.290.5490.262

FDA Clinical Investigator Site Inspections: The Sponsor’s Role

Once a New Drug Application (NDA) is submitted to the Food and Drug Administration (FDA) for review and potential approval, it is likely that at least some of the clinical trial investigators will be inspected by the FDA. Study issues of noncompliance and/or data integrity can result in costly approval delays. This paper will describe the role of the sponsor in dealing with an FDA clinical trial site inspection including selection of clinical trial sites, timing of sponsor inspections, site coaching, and the sponsor’s role during and after the FDA inspection. This preinspection program has been viewed as beneficial by company management and Eli Lilly and Company trial investigators who have been investigated. It is believed that the FDA benefits as well, by assuring that site documents and staff are in readiness for an efficient inspection.

Standardization of Report Formats for Chemistry/Pharmacy Documents

Review of the chemistry/pharmacy sections of submissions by regulatory agencies has frequently resulted in deficiency letters from these agencies. Addressing regulatory agency letters typically requires an extensive use of time and resources. The worst case scenario is if preparation time for a response letter translates into a delay in product approval. Lack of accessibility of information within documents in a submission has been identified as a root cause of regulatory agency questions. As a potential solution to the problem, standard report guidelines are being developed within American Cyanamid Co. for all key chemistry/pharmacy submission report types. Each report guideline contains the report data requirements, the standard report format, an electronic template, and detailed instructions on report preparation. Four standard report guidelines have been completed and are implemented at this time. A scientific writing course was tailored to each guideline, with the assistance of a specialty writing co...

The Effects of Design Changes and Delays on Project Costs

This paper describes a study of a large design and manufacture engineering project, undertaken as part of a Delay and Disruption litigation. Design changes and delays in design approval would have caused delay to the project; in order to fulfil a tight time-constraint, management had to increase parallel development in the network logic, reducing delay but setting up feedback loops that markedly increased total project spend. Cognitive mapping was used to elicit the relationships, which suggested the use of System Dynamics to quantify the effects. Results are described that show the effect of levels of design changes and approval delays, and their compounding effect. The wider implications on modelling projects are also discussed.

Existing problems in the testing for infectious diseases.

Current methods for testing donated blood for presence of infectious viral agents in the USA differ from those used in other countries because of the USA Food and Drug Administration's (FDA) control which inhibits rapid introduction of testing methods or improvements. Delays in FDA approval may occur because of concerns about methodology or the state of knowledge about the disease it is intended to detect as well as due to variability between manufacturers. Despite strict FDA control, testing problems continue to occur in the USA. No approved method detects infectious agents during the "window period," and variations in detection, i.e., false positives and false negatives (even with confirmatory testing), continue to occur. The effect of physical and chemical changes (e.g., various anticoagulants) on samples has not been thoroughly evaluated. Test performance problems include lapses in sample identification, failure to use routine laboratory controls, improper calculation and reporting of results, improper acceptance of test runs and failure to properly detect and retest samples when carryover from very reactive samples occurs. For these reasons, transfusion-related disease transmission continues to occur. The current USA emphasis on good manufacturing practices should provide continuous improvements.

Biotechnology Industry Calls for Active US Role

SIGNS that the biotechnology industry is not growing as fast in the mid 1990s as it did in the 1980s have the industry's members, academic leaders, and investors worried. They have joined in an effort to halt any further erosion and to shape a national agenda to ensure United States preeminence in biotechnology. If the meeting they held in Washington, DC, described as the National Biotechnology Summit, did not exactly allay the industry's fears for the future, it did examine some of the problems the industry faces. Speaker after speaker pointed with alarm to cuts in federal funding for medical research, delays in drug approval, and doubts about the way new drug price controls, likely to be incorporated into health system reform legislation, may work. Expensive Toys? More than one speaker called up the specter of an administration that they say views new medical technologies as expensive toys to be

Factors affecting the relationship between contractors and their sub‐contractors in Saudi Arabia

Delay in contract progress payment, lack of construction quality, errors and delay in shop drawings and/or approval of sample materials were ranked highest as interface problems, whilst legal disputes, scheduling conflicts amongst sub‐contractors, geological problems and weather conditions were ranked lowest.

Scientific literacy and environmental policy: the missing prerequisite for sound decision making

Introduction The Setting Prologue: Regulation in General Policy Formulation at the Intersection of Law, Science and Technology Implications for the Real World Collisions and Implications for Societal Scientific Literacy Revolution in Pharmaceutical Innovation and Evolving Policy Regulation, Voices of the Public, and Pharmaceutical Innovation: Implications of Delays in FDA Approval of New Drugs Regulation, Voices of the Public, and Pharmaceutical Innovation: The Quandary Goes On Regulation, Voices of the Public, and Products of Recombinant DNA: Science and Technologies Regulation, Voices of the Public, and Products of Recombinant DNA: The Intersection with Policy and Law At the Intersection: Disenfranchisement and Reenfranchisement At the Intersection: Merge, or Collision? Can We Reenfranchise Society for the Intersection? Epilogue: Future History Selected Bibliography Index

European Commission questions German approval delays

European Commission questions German approval delays

FDA Audits of Clinical Studies: Policy and Procedure

The Food and Drug Administration has been conducting audits of the work of clinical investigators since 1962, and has done so on a routine basis since 1977. Since 1977 the work of approximately 2,800 drug investigators has been subject to inspection; approximately 500 of these have been "for cause," including 49 performed outside of the United States. The routine audits are done on studies important to the FDA's approval of therapeutic claims, and are thus not targeted at the investigator, but at the validity of the study. Nevertheless, problems with consent were found in 54%; inadequate drug accountability in 25%; nonadherence to the protocol in 26%; inadequate and inaccurate study records in 21%; problems with institutional review board notification/approval in 13%; nonavailability of study records in 3%; and inappropriate delegation of authority in 4%. Ten percent of routine inspections revealed deficiencies of frequency and/or magnitude sufficient to warrant follow-up activity. We believe that this figure represents the only available assessment of the incidence of scientific misconduct. Of interest is a decrease to 6% in the past few years. "For cause" inspections may be either investigator-targeted or study-targeted. The former have resulted in regulatory action in 100 cases and successful criminal prosecution in 16. The latter have resulted in nonapproval or delay of approval of drugs for marketing. A subset of study-targeted inspections is the foreign inspections performed on studies important to U.S. approval of claims of efficacy of 24 drugs.(ABSTRACT TRUNCATED AT 250 WORDS)

FDA advisory committees and the new drug approval process.

To determine the impact of FDA advisory committee review on the approval time of new drug applications (NDAs) approved during the five-year period 1983 through 1987, we compared NDA phase lengths of reviewed new chemical entities (NCEs) with those that were not reviewed and examined the elapsed time from final committee recommendation for approval to NDA approval. Of the 95 drugs approved during the study period that met the Center for the Study of Drug Development's definition of an NCE, 40 (42%) were submitted for review--mean NDA phase length was 36.9 months versus 32.4 months for unreviewed drugs. Reviewed drugs in the neuropharmacologic division had a longer NDA phase, while those in the metabolic/endocrine and oncology/radiopharmaceutical divisions had shorter NDA phases, than unreviewed drugs in those divisions. For NCEs grouped by therapeutic rating, reviewed drugs in each category had longer NDA phases than unreviewed drugs; the difference was largest for 1-B rated drugs. The elapsed time from committee recommendation for approval to NDA approval as a percent of the total NDA phase was greatest for drugs submitted by the metabolic/endocrine division (83.0% of NDA phase) and for drugs rated 1-A (63.2%). Results indicate that advisory committee review is associated with a small overall delay in NDA approval when compared with the regulatory fate of drugs not submitted for review.

Examining the Process to Determine the Program for CEC's International Convention

Examining the Process to Determine the Program for CEC's International Convention As Program Chairperson for CEC's 1988 Annual International Convention, I have had a unique opportunity to become familiar with the process used for determining professional sessions to be included. Most of the problems, suggestions for improvement, ideas, and criticisms related to the process used for selection of papers and other aspects of the annual convention reach the program chairperson. This commentary provides insight into the process and information that could be helpful to planning to submit a proposal in response to the annual Call for Papers. OVERVIEW OF THE PLANNING PROCESS The location of the annual convention is determined 5 years before the convention by the Executive Committee, but the actual work to plan the professional sessions begins about 2 years before the particular convention. The First Vice President is elected during the annual convention and takes office the following July 1st. The First Vice President, among other duties, serves as the Program Chairperson for the convention that will be held in the second year from when he or she was elected. During the convention preceding the convention for which the First Vice President is responsible, he or she meets with the Program Advisory Committee (PAC). The PAC varies in size from year to year, but for the 1988 convention it consisted of 40 persons, 28 of whom were assigned a varying number of slots to fill. The PAC members have traditionally included a representative from each of the divisions, usually the president elect (there are currently 14 divisions); from the Office of Special Education Programs responsible for strands, crackerbarrels, and sessions; a representative of the exhibitors; the Student CEC Vice President for Programs; and chairpersons of most of CEC's standing committees. During the summer before the convention, papers submitted in response to the Call for Papers are sent by the Program Chairperson to the PAC members responsible to fill slots. The PAC members determine which papers to select and assign times and days for the presentations. The PAC members are also responsible for notifying the who had submitted the proposals of their acceptance and of the time scheduled. The Program Chairperson approves each of the sessions accepted and communicates this to CEC Headquarters staff who then work on the advance information and the myriad of other details that the staff handles. A rigid time schedule has been established over the years to accomplish the selection of the proposals by a PAC whose members are spread across the United States and Canada. The system depends upon the people on the PAC, the Program Chairperson, and the Headquarters staff doing their jobs and doing them on time. There are many opportunity for breakdowns. Some of the problems we experienced as we worked on the 66th Convention included packets of proposals intended for PAC members were lost/delayed in the mail; some were not notified that their proposals had been accepted on the intended schedule; and there were various deadlines missed which created extra work and concern. PROPOSALS SUBMITTED FOR THE 1988 CONVENTION The deadline to receive proposals was announced as May 30, 1987, and 997 proposals were received postmarked on or before the deadline. Of these proposals, 54 were returned because they listed presenters already included in a previously received The Call for Papers had clearly stated that persons submitting a proposal involving others should check to be certain that the individuals listed are not also committed to another program Failure to do so may result in delay of program approval or outright rejection of the proposal. Some sent more than one proposal, resulting in the return of all of their proposals other than the first one. …

The social drug lag: An examination of pharmaceutical approval delays in medicaid formularies

Several states have enacted restrictive drug formularies in order to control the costs of their Medicaid pharmaceutical programs. This study investigates the restrictiveness of these formularies by analyzing the delay in approving new drug products for Medicaid reimbursement. A restrictiveness index is developed which relates the drug product months which are denied to Medicaid patients to the potential product months of availability if all products which were newly approved for general use were simultaneously made available to the Medicaid population. The study then relates the restrictiveness of state formularies to Medicaid drug program costs and to total Medicaid program costs. We find that restrictiveness of formularies is not associated with lower drug costs, but that total Medicaid costs are lower in states with more restrictive formularies. We suggest that restrictive formularies may occur in states with other Medicaid cost-containment measures, so that total Medicaid exoenditures are contained in those states, even though there is no reduction in drug expenditures.