FDA’s Draft Guidances for the calendar year 2017

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has published a Guidance Agenda with planned new and revised Draft Guidances for the calendar year 2017.

Changes are expected within documents of several categories: Advertising, Biopharmaceutics, Biosimilarity, Clinical/Antimicrobial, Clinical/Medical, Clinical Pharmacology, Clinical/Statistical, Drug Safety, Electronic Submissions, Generics, Labeling, Pharmaceutical Quality/CMC, Pharmaceutical Quality/Manufacturing Standards (CGMP), Pharmacology/Toxicology, Procedural, User Fees