The Food And Drug Administration Modernization Act Of 1997

895 Words 4 Pages
I am working in a very small biotech company and responsible person to submit our product related document to the FDA. We just got a letter from FDA that our product is approved and we have to signed postmarketing commitment (Phase IV Trial). I am going to discuss this matter with my boss. It is a signed commitments with FDA given by a sponsor before or after product approved by FDA to gather additional information about a product 's safety, efficacy, or optimal use.
The Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Food, Drug and Cosmetic Act signed into law on November 21, 1997 by adding a new section 506B (21 U.S.C. 356b). FDA issued a draft guidance related to this rule in April 2001. This section provides additional authority to the FDA to monitor the progress of postmarketing studies that drug and biologic are safe for long term use and to update drug labeling with information obtained from such studies. It is a sponsor responsibility to submit postmarketing study progress report annually to FDA who publishes this report annually in the federal Register. The reason behind phase IV trial requirement is that a drug or biological product approved on the basis of animal efficacy data because human efficacy studies are not ethical or feasible, an applicant must conduct studies when ethical and feasible to verify and describe clinical benefit and to assess the product’s safety as per 21 CFR 314.610(b) (1) and 601.91(b) (1). A sponsor must file

Related Documents