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The FDA has issued a direct-to-final guidance on using benzene in drug manufacture and has revised a recently issued draft guidance on topical ophthalmic drug quality, an area in which the agency has seen significant quality control issues recently. Read More
Since both programs accept limited clinical evidence for investigational products, sponsors can establish specification acceptance criteria wider than the actual test results. Read More
As 2023 draws to a close, the FDA has issued several final guidances, including documents on collecting trial data with digital health technologies, developing rare disease drugs and biologics, and complying with a final rule on TV and radio prescription drug ads, as well as a new draft guidance on clinical trial master protocols. Read More
Ultragenyx Pharmaceutical has agreed to pay $6 million to resolve allegations that it caused the submission of false claims to Medicare and Medicaid, according to the Department of Justice (DOJ). Read More
CDER has developed a new adaptive crossover trial design that can be used in demonstrating the bioequivalence (BE) of generic versions of drugs with high pharmacokinetic (PK) variability. Read More
A newly published Q&A document from the FDA and the European Medicines Agency (EMA) outlines the similarities — and differences — in the two agencies’ requirements for manufacturing breakthrough products. Read More
In a final guidance issued this week, the FDA outlines recommendations for continued development of monoclonal antibody products targeting SARS-CoV-2 to meet emergency needs. Read More
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published an AI workplan intended to create a collaborative and coordinated strategy that will maximize AI’s benefits while managing the risks. Read More