Draft Guidance and a MaPP to Help Firms and Reviewers Get It Right the First Time (or Second Time)

Today, the FDA issued a draft guidance entitled “Good ANDA Submission Practices” (here) along with a new Manual of Policy and Procedure (MaPPs) 5241.3, entitled “Good ANDA Assessment Practices: Manual of Policies and Procedures.” These establish good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their operational efficiency and effectiveness.

New Year – New Class Labeling for Combined Hormonal Contraceptives

It has been quite a while since FDA totally updated the class labeling guidance for combined hormonal contraceptives (CHC).  FDA notes “this newer CHC labeling may be different from the labeling for some older CHC products. The updates to this guidance set forth labeling recommendations that represent newer class labeling that should be included in all CHC prescribing information consistent with the labeling requirements set forth in the PLR and PLLR (21 CFR 201.56 and 201.57)…”  There have been some minor modifications such as the “Content and Format of Labeling for Human Prescription Drug and Biological Products;

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