We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The FDA is taking public comments ahead of a United Nations meeting that plans to add 10 drugs to international lists of controlled substances, including several relatives of powerful street drugs. Read More
The FDA is clearing up its annual reporting requirements for wholesale distributors and third-party logistics providers (3PL), explaining who must report and when to submit filings, among other clarifications, in a draft Q&A guidance. Read More
The Supreme Court has rejected Mylan’s challenge to a Federal Circuit decision that generic-drugmakers can face patent suits anywhere they may make sales in the future. Read More
The International Generic Drug Regulatory Program has outlined the group’s priorities for the next four years, focusing on five initiatives geared toward harmonizing global regulations on generic drugs. Read More