Drugs

Amended Sanofi Warning Letter

FDA has issued an amended Warning Letter to Sanofi, replacing the 12/16/2024 letter addressing significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs) found in a 6/12-7/9/2024 inspection at the firm’s Genzyme Corp. subsidiary in Framingham, MA. The amended letter says the specific Genzyme deviations were:

failure to investigate all critical deviations;
failure to demonstrate that the manufacturing process can reproducibly manufacture APIs meeting predetermined quality attributes;
failure to have equipment of the appropriate design and suitability for their intended use to manufacture APIs;
failure of the firm’s quality unit to exercise its responsibility to ensure the APIs manufactured at the facility comply with CGMP; and
failure to ensure all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions recorded.

The letter says that its significant findings indicate that the firm’s quality unit is not able to fully exercise its authority and/or responsibilities. “Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality,” it says.

Genzyme was told to correct deviations promptly and to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome