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The agency plans on publishing more than 100 new or revised guidance documents in 2017.
On January 11, 2017, FDA released the Center for Drug Evaluation and Research’s (CDER) guidance agenda for 2017, which includes more than 100 guidance documents to be published this year. The list includes new and revised draft guidance documents with topics ranging from biopharmaceutics to clinical, to quality, to labeling, and more.
Of the guidance documents CDER plans on publishing, pharmaceutical manufacturers may be most interested in the following:
A few of the guidance documents that biopharma manufacturers may specifically be interested in include the following:
Generic-drug manufacturers may want to look out for the following:
Additional planned guidance documents include those on labeling, quality, post-approval changes, packaging, and user fees.