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FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.
On Jan. 22, 2016, FDA’s Center for Drug Evaluation and Research (CDER) announced their agenda for new and revised draft guidance documents the center plans on publishing in 2016. Of the approximately 100 draft guidance documents the center plans on publishing in 2016, the majority address clinical, quality, and procedural issues. Other popular pharmaceutical topics addressed include generic drugs and labeling.
The following are some highlights from the agenda by category.
Pharmaceutical quality/chemistry, manufacturing and controls (CMC)
The agenda also includes a variety of Drug Supply Chain Security Act (DSCSA) implementation and Pediatric Research Equity Act (PREA) guidance documents.
The full list can be found on the FDA.gov website.