CDER Guidance Agenda for 2019: What’s Coming

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue almost 100 new draft and revised draft guidance documents spanning 15 different categories, from biosimilars to clinical pharmacology to drug safety, in 2019.

The bulk of the guidance documents are contained in three categories: clinical/medical, pharmaceutical quality/CMC and procedural.

The guidance in clinical/medical focuses on specific types of development programs for certain products intending to treat attention deficit hyperactivity disorder, gastroparesis, eosinophilic esophagitis, heart failure and more. Other notable guidance documents focus on bispecific antibodies and cross labeling oncology drugs in combination drug regimens.

Under the category of pharmaceutical quality/CMC, CDER is planning to issue guidance on risk management plans, the inspection of injectables for visible particulates, stability considerations and quality considerations for topical ophthalmic products, among others, as well as a revised draft guidance on drug master files (which was also on last year’s guidance list).

And under the category of procedural guidance, FDA is planning to issue documents on civil monetary penalties for failure to meet accelerated post marketing requirements (also on last year’s list), submitting documents utilizing real-world data and real-world evidence, public disclosure of FDA-sponsored studies, tropical disease priority review vouchers and a question and answer document on risk-based approaches to the monitoring of clinical investigations.

Other notable guidance documents include one for biosimilars sponsors on comparative analytical assessments, which follows FDA's decision last June to withdraw a draft guidance on biosimilar analytical studies. In addition, CDER is planning two revised draft guidance documents on pediatric product development, three-year exclusivity determinations for generic products and multiple guidance documents on postmarketing studies and safety reporting.

Guidance Agenda: New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2019