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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