Food And Drug Administration Labeling Research Articles

FDA Labeling System for Drugs in Pregnancy

OBJECTIVE:To review the current Food and Drug Administration (FDA) pregnancy labeling system, examine the new FDA-proposed pregnancy labeling system for form and content, and provide comments on its suitability for implementation.DATA SOURCES:Data were obtained from the FDA's Web site (www.fda.gov), PubMed, Federal Register, LexisNexis, Physician's Desk Reference (PDR), Drugdex, and Current Contents.STUDY SELECTION:Research and articles involving drugs and pregnancy, drugs and lactation, and the subcommittee meeting of the FDA were included.DATA EXTRACTION:Prospective, case-control studies from pregnancy registries.DATA SYNTHESIS:Currently, only 40% of drugs in the PDR have pregnancy categories listed. The medical profession has resorted to other means to assess pregnancy risk, such as retrospective chart review, case reports, and consultation with experts such as regional drug information centers.CONCLUSIONS:The proposed pregnancy labeling system strives for more clinical usefulness by reliance on human data derived from pregnancy registries. The clinical usefulness of the new labeling remains to be seen.

FDA Labeling System for Drugs in Pregnancy

To review the current Food and Drug Administration (FDA) pregnancy labeling system, examine the new FDA-proposed pregnancy labeling system for form and content, and provide comments on its suitability for implementation. Data were obtained from the FDA's Web site (www.fda.gov), PubMed, Federal Register, LexisNexis, Physician's Desk Reference (PDR), Drugdex, and Current Contents. Research and articles involving drugs and pregnancy, drugs and lactation, and the subcommittee meeting of the FDA were included. Prospective, case-control studies from pregnancy registries. Currently, only 40% of drugs in the PDR have pregnancy categories listed. The medical profession has resorted to other means to assess pregnancy risk, such as retrospective chart review, case reports, and consultation with experts such as regional drug information centers. The proposed pregnancy labeling system strives for more clinical usefulness by reliance on human data derived from pregnancy registries. The clinical usefulness of the new labeling remains to be seen.

FDA Regulation of “Medical Foods”-An Industry Perspective

Abstract Since the early 1970s, the Food and Drug Administration (FDA) has accepted the premise that a nutrient formulation could be represented as meeting the special nutritional needs of a person with a disease or a medical condition, without triggering drug status for the product, and has subsequently defined and refined the concept of “special dietary foods that are intended for use solely under medical supervision to meet nutritional requirements in specific medical conditions.” The term “medical food” refers to a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. As the number and diversity of products marketed under the medical food category has increased, the FDA has attempted to clarify what products qualify under the category. Classification as a medical food confers significant advantages on a product, exempting it from various FDA labeling requirements that apply to conventional foods. Because the statutory guidelines are so sparse, developers of medical foods are looking to correspondence between FDA inspectors and medical foods manufacturers, to clarify the regulatory status of their products.

Fda Regulation of “Medical Foods” — An Industry Perspective

Since the early 1970s, the Food and Drug Administration (FDA) has accepted the premise that a nutrient formulation could be represented as meeting the special nutritional needs of a person with a disease or a medical condition, without triggering drug status for the product, and has subsequently defined and refined the concept of special dietary foods that are intended for use solely under medical supervision to meet nutritional requirements in specific medical conditions. The tenn medical food refers to a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. As the number and diversity of products marketed under the medical food category has increased, the FDA has attempted to clarify what products qualify under the category. Classification as a medical food confers significant advantages on a product, exempting it from various FDA labeling requirements that apply to conventional foods. Because the statutory guidelines are so sparse, developers of medical foods are looking to correspondence between FDA inspectors and medical foods manufacturers, to clarify the regulatory status of their products.

FDA labeling requirements for disinfection of endoscopes: a counterpoint.

Endoscopes are used widely for the diagnosis and therapy of medical disorders. To prevent spread of nosocomial infection, all endoscopes should undergo thorough cleaning and high-level disinfection following each use. The Food and Drug Administration (FDA) has approved a user-friendly package label for one liquid chemical germicide that requires a 45-minute immersion at 25 degrees C to support a high-level disinfection label claim. Scientific data reviewed here suggest that one can achieve at least an 8-log reduction in M tuberculosis contamination with cleaning (4 logs) followed by chemical disinfection for 20 minutes (4 to 6 logs). The FDA should modify the label to state that if cleaning is accomplished using a standardized cleaning protocol, then a 20-minute immersion at 20 degrees C will be sufficient to achieve high-level disinfection.

FDA Labeling Requirements for Disinfection of Endoscopes: A Counterpoint

Endoscopes are used widely for the diagnosis and therapy of medical disorders. To prevent spread of nosocomial infection, all endoscopes should undergo thorough cleaning and high-level disinfection following each use. The Food and Drug Administration (FDA) has approved a user-friendly package label for one liquid chemical germicide that requires a 45-minute immersion at 25°C to support a high-level disinfection label claim. Scientific data reviewed here suggest that one can achieve at least an 8-log reduction in M tuberculosis contamination with cleaning (4 logs) followed by chemical disinfection for 20 minutes (4 to 6 logs). The FDA should modify the label to state that if cleaning is accomplished using a standardized cleaning protocol, then a 20-minute immersion at 20°C will be sufficient to achieve high-level disinfection.