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Testimony: FDA Commissioner says FDA has limited authority over compounding pharmacies to prevent meningitis outbreak
FDA Commissioner Margaret Hamburg was asked if the fungal meningitis outbreak could have been prevented by FDA during a 4-hour hearing Nov. 14 headed by the chairman of the House Energy and Commerce oversight subcommittee. Her answer was that FDA had limited authority because the New England Compounding Center (NECC), Framingham, Mass., was a ?compounding pharmacy,? which is regulated by the state Board of Pharmacy.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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