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The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT). Read More
The FDA will kick off the new year under another possible threat of a shutdown because lawmakers have so far failed to agree on fiscal 2024 funding for the federal government and stopgap funding is set to expire on Jan. 19 — just over one week after the House and Senate begin the new session. Read More
The guidance was issued without inviting public comment due to “the immediate public health need to expedite the discontinuation of the use of these carbomers.” Read More
Amazon was hit with its third FDA warning letter of the year last week, this time for selling unapproved and incorrectly labeled products that contain the active ingredient in erectile dysfunction (ED) drugs Cialis and Viagra. Read More
The drug was approved in 2018 to treat X-linked hypophosphatemia (XLH), a rare form of rickets characterized by low levels of phosphate in the blood. Read More
The FDA has issued a direct-to-final guidance on using benzene in drug manufacture and has revised a recently issued draft guidance on topical ophthalmic drug quality, an area in which the agency has seen significant quality control issues recently.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disease drugs and biologics, and complying with a final rule on TV and radio prescription drug ads, as well as a new draft guidance on clinical trial master protocols.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