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A student group that filed a citizen petition aimed at improving what it alleges are “hugely deficient” trial reporting enforcement efforts by the FDA has gained some ground in the ongoing effort to increase trial transparency, with the agency granting one of its requests and pledging to consider another. Read More
The FDA is withdrawing its approval of Oncopeptides’ multiple myeloma drug Pepaxto (melphalan flufenamide), effectively ending a three-year tug-of-war over the controversial drug’s future. Read More
A robust package of success stories highlights the FDA’s Office of Generic Drugs (OGD) 2023 Annual Report, with ample credit given to Congress’ reauthorization of a program ensuring safe and effective generic medicines. Read More
Wholesale drug acquisition and distribution stakeholders say that even by November, the industry won’t be ready to comply with the Drug Supply Chain Security Act’s (DSCSA) updated security requirements. Read More
The FDA has issued a new final guidance on assessing COVID-19-related symptoms in drug and biologics trials for outpatient prevention/treatment of the infectious disease, overriding its prior recommendations from September 2020. Read More
Over the past week, the FDA issued a final rule adding the Digital Health Advisory Committee to the list of standing committees, final guidance on COVID-19 symptoms in clinical trial subjects, and draft guidance on medical device user fees for small businesses. Read More
While three of the companies warned of inappropriate Orange Book patent listings by the FTC are delisting all the challenged patents, according to the U.S. legislators who led the action, five others refused to delist. Read More
The rationing scheme allegedly led to the death of one patient in 2010, and injured the health of four others, who were co-plaintiffs in the case. Read More
Chinese pharmaceutical company Sichuan Deebio Pharmaceutical has suspended manufacture of at least one active pharmaceutical ingredient bound for the U.S. marketplace and may be banned from importation altogether if it doesn’t correct multiple deficiencies cited in a scathing 483 inspection report, according to a warning letter issued earlier this month. Read More
This edition of Quick Notes looks at significant drug approvals, including the first cellular therapy for patients with unresectable or metastatic melanoma, a drug to reduce accidental food allergy reactions, Tagrisso with chemotherapy for patients with EGFR-mutated advance lung cancer and a dosage reduction for patients with relapsed or refractory multiple myeloma. Read More