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The FDA issued a draft guidance on the preliminary request for designation process, and what information to include. The pre-RFD process provides informal, non-binding feedback on the regulatory identity or classification of a drug, biologic or combination product. Read More
The FDA issued a draft and a separate final guidance dealing with when the agency would exercise enforcement discretion for certain violations covering repackaging products. The draft addresses biologics, while the final guidance deals with drugs. Read More
The FDA responded to commonly raised questions about the 180-day exclusivity for generics in a draft guidance document covering everything from patents to forfeitures. Read More
The FDA will proceed with using a nonproprietary naming approach that relies on arbitrary four-letter suffixes to distinguish biosimilars and biologics, showing a disregard for industry concerns in a lightly tweaked final guidance that adds a few new considerations for suffix proposals. Read More
President-elect Donald Trump met with two west-coast venture capitalists Thursday who are being considered for top positions at the FDA, according to spokesman Sean Spicer. Read More
Generic drug applications surged in December, with the FDA receiving 235 ANDAs — the second-highest submission record for a particular month since the implementation of GDUFA. Read More
The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain requirements. Read More
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. Read More
Donald Trump led off his first press conference as president-elect by taking shots at the pharmaceutical industry, saying they are “getting away with murder” with high drug prices, and pledged to create new bidding procedures to lower prescription costs by “billions of dollars.” Read More