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Over the past week, the FDA issued several guidance documents — including a final guidance on developing nicotine replacement therapy drug products, a final guidance on quality risk management and a draft guidance on decentralized clinical trials for drugs, biological products and devices. Read More
Over the past week, the FDA issued an authorization of a medical device, a request for comments for a public workshop and proposed data and information collections. Read More
Over the past week, the FDA issued a correction of a docket, an authorization and two revocations of diagnostic devices and a request for comments on rapid response surveys. In addition, the agency announced a public workshop. Read More
Over the past week, the FDA issued two final and three draft guidances, as well as requests for comments on several advisory committee meetings, user fees, IND applications and the agency’s data and technology strategic plan. In addition, CDRH released details of the center’s Radiation Sterilization Master File Pilot Program. Read More