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As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Sterile drug manufacturer Eugia SEZ Private Limited’s February FDA inspection resulted in a Form 483 laden with examples of the company failing to follow procedures to prevent microbiological contamination of its drug products among seven observations of other lapses. Read More
Four units within the FDA have worked together to publish a paper to provide greater transparency on how they will collaborate with the pharmaceutical industry as it develops and deploys AI technologies. Read More
Despite a potential increase in the risk of death, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted Friday in support of two already approved multiple myeloma CART-T cell treatments in earlier stages of the disease. Read More
The FDA has issued a final guidance on the process generic drug manufacturers can use to correspond with the agency on generic drug development, the agency’s process for responding and for manufacturers to clarify ambiguities in what the FDA refers to as “controlled correspondence.” Read More
In a 12 to 2 vote Thursday, an FDA advisory committee gave a thumbs up to Geron Corporation’s imetelstat for treating transfusion-dependent (TD) anemia in adults with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS), who are ineligible or don’t respond to erythropoiesis-stimulating agents (ESAs). Read More
Over the past week, the FDA issued final guidance on assessing COVID-19 symptoms in adult and adolescent clinical trial subjects. Draft guidances were issued covering drug development for early onset Alzheimer’s disease, labeling changes for nonprescription drug NDAs and ANDAs, updates for the premarket cybersecurity guidance, E2D(R1) postapproval safety data, thermal effects of tissue heating and/or cooling medical devices and the Q-Submission program. Read More
The FDA’s approval on Thursday of Madrigal Pharmaceutical’s Rezdiffra (resmetirom) is the first for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). Read More
Stool for Fecal Transplants Company Earns FDA Warning Letter
Teaser: The Warning Letter confirms that the organization must have an FDA-approved BLA confirming the product is safe, pure and potent. Read More
The FDA’s legislative wish list for FY 2025 includes proposals to protect drug supply resiliency, amend the Hatch-Waxman Act, and exercise greater control over recalls. Read More