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CBER released an updated list of guidances it plans to publish this year, including draft recommendations on the following gene therapy topics: Read More
Regulators might be willing to approve heart failure drugs that make patients feel better even if they don’t keep patients out of the hospital — or even alive, the FDA said in a new draft guidance document issued Thursday. Read More
Woodcock highlighted a proposal in the administration’s budget request that would impact the 180-day exclusivity available to first filers of medications. Read More
The agency recommends that companies “consider providing information on whether their drug has any characteristics that would mitigate the risks of overdose, abuse or the development of addiction.” Read More
Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on GMP clearance regulations for overseas manufacturing facilities, clarifying the agency’s processing timelines for various applications. Read More
The FDA is turning to the public for comment on two International Council for Harmonisation draft guidance documents, one designed to help move clinical trials along more quickly, the other designed to make sure that researchers are getting the best possible data before trials can get started. Read More