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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
Two weeks past its deadline, the Environmental Protection Agency (EPA) announced its final amendments to the air toxics standards for ethylene oxide (EtO) commercial sterilization facilities, calling the additions “the strongest measures in U.S. history to reduce emissions of EtO, one of the most potent cancer-causing chemicals.” 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
Last month, signs that magrolimab increases the risk of death prompted Gilead to shelve the drug for blood cancer, Vertex’s second-gen cystic fibrosis combo leaves the company’s first-gen efforts in the dust, a new drug combo looks promising for multiple myeloma, and Regenxbio hopes to snag an Accelerated Approval for a new rare disease gene therapy. Also, Astra Zeneca is touting “major advance” in treating one type of non-small cell lung cancer. Read More
Par Pharmaceutical, a subsidiary of Endo International, announced a voluntary recall of one lot of treprostinil injection 20mg/20mL due to the potential for the presence of silicone particulates in the product solution. Read More
The FDA’s latest two draft guidances on medical devices address the ways in which submitters can request interactions with the agency and evaluating the thermal effects of devices that heat or cool tissue. Read More