CDER Outlines 2017 Draft Guidance Agenda

CDER published an agenda of 101 upcoming draft guidances for the 2017 calendar year — including new recommendations for securing user fee waivers, formatting REMS documents, and details on fines for failing to meet postmarketing requirements after accelerated approval.

Other draft guidances in the works cover advertising and communications between manufacturers and payers, formularies and other committees; safety data considerations for rare disease development; and fees incurred under the Drug Supply Chain Security Act — as well as question and answer documents on 180-day generics exclusivity and the qualified infectious disease product designation.

The agency also plans to revise its draft guidances on pediatric oncology development and required pediatric study compliance, postmarket safety reporting for drugs and biologics, and the content of ANDA submissions — as well as eight separate guidances covering clinical pharmacology topics, such as drug interactions, population pharmacokinetics, and exposure-response relationships.