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The FDA's Center for Drug Evaluation and Research (CDER) is planning to develop nearly 50 new guidances this year, including recommendations on direct-to-consumer advertising and product labeling, according to CDER's recently released guidance agenda.
The FDA issued a final rule late last month to address the reclassification of a dental bone grafting product from Class III to Class II with special controls — a decision that paved the way for the reclassification of other dental bone grafting materials.
The FDA has released a draft guidance on toxicity grading scales for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Standardized toxicity assessment scales are widely used to evaluate products designed to treat specific diseases.
The FDA’s planned Drug Watch website is not intended to be a list of drugs that are particularly risky, according to a new draft guidance that cautions drugmakers to be careful in using the information for marketing purposes.
Drugmakers need to be careful about how they use information posted on the FDA's planned Drug Watch website, especially if that information is to be used for marketing purposes, according to a newly released draft guidance about the website.
The FDA’s Center for Biologics Evaluation and Research (CBER) has released a draft guidance on toxicity grading scales for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials.
Manufacturers should begin submitting electronic labeling changes for previously approved drugs in structured product labeling (SPL) format by fall 2005, according to a recently issued final FDA guidance.
An FDA guidance recently published in the Federal Register states that combination product manufacturers can cut their application user fees by as much as 50 percent if their products meet the requirements set by the “barrier to innovation” waiver established by the Prescription Drug User Fee Act (PDUFA).
AdvaMed updated its “Code of Ethics” April 18 to include answers to more specific questions concerning gifts and other types of financial support that members may provide to healthcare professionals.