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The FDA has accused Procter & Gamble (P&G) of submitting one ingredient list for Nyquil to the agency and using a different one for the over-the-counter product’s physical labeling. Read More
The FDA appears to be casting a favorable eye on Biogen’s SOD1-amyotrophic lateral sclerosis drug tofersen, suggesting that reductions in neurofilament light, a protein associated with neuronal damage, could support an Accelerated Approval. Read More
CDER’s Office of Compliance issued 101 warning letters in fiscal 2022 — about two-thirds of them related to COVID-19 products, according to the office’s latest annual report. Read More
The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that. Read More
Novo Nordisk will undergo audits in 2023 and 2024 to check for “clear, significant, and then sustained improvement” in its compliance with the industry standards. Read More
Scientists working in the FDA’s and European Medicines Agency (EMA)’s parallel scientific advice (PSA) program kept the numbers of accepted requests from sponsors level despite needing to shift many resources to address COVID-19 related public health needs, according to a new review of the program’s productivity over the last five years. Read More
U.S. District Judge Matthew Kacsmaryk, the Texas federal judge who could outlaw the abortion pill, mifepristone, said he will render a decision on the case “as soon as possible.” Read More
The FDA clarified the agency’s interpretations of what is meant by “suspect” and “illegitimate” products in the Drug Supply Chain Security Act (DSCSA) in a final guidance released Thursday. Read More