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The FDA center released its list of planned guidance documents for the rest of the year.
FDA’s Center for Drug Evaluation and Research (CDER) released its planned 2018 agenda for guidance documents on Jan. 19, 2018. The center plans on publishing approximately 107 guidance documents this year discussing topics ranging from advertising, clinical, development, safety, approval submissions, generics, labeling, and more.
Specific topics to be addressed by CDER this year include biomarker qualification, postmarket safety reporting, electronic regulatory submissions, drug master files, CMC approval requirements, opioid products, rare diseases, and user fees.
The agency also has a variety of guidance documents addressing generic drugs and abbreviated new drug applications. Exclusivity, topical patches, and bioequivalence studies are some of the generic drug topics discussed.