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Medical Devices Need Top Priority in Supply Chain, Conference Speakers Say
Within the supply chain universe, medical technology and its countless components needs to stay front and center when competing with other industries, emphasized the FDA’s lead officer on the subject during a two-day workshop on generic drug-device combination products last week. Source: Drug Industry Daily
Read MoreLegislative Update — Week of March 18, 2024
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. Source: Drug Industry Daily
Read MoreIndian Chemotherapy Drug Manufacturer Dinged With 483
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. Source: Drug Industry Daily
Read MoreFDA Outlines Areas of Focus for the Development and Regulation of AI Technologies
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. Source: Drug Industry Daily
Read MoreAdComm Supports Using Two Approved CAR-T Cancer Treatments Earlier in Multiple Myeloma
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. Source: Drug Industry Daily
Read MoreFDA Finalizes Controlled Correspondence Guidance for Generic Drugmakers
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.” Source: Drug Industry Daily
Read MoreFDA Panel Endorses Geron’s Anemia Drug for Group of Blood Cancers
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). Source: Drug Industry Daily
Read MoreRegulatory Update — Week of March 11, 2024
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…
Read MoreFirst Treatment for NASH Gets FDA Approval
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). Source: Drug Industry Daily
Read MoreEPA Publishes Final EtO Amendments Aimed at Reducing Emissions by 90 Percent
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.” Source: Drug Industry Daily
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