CGMP/Finished Pharmaceuticals/Adulterated
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Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle
Foster City, Calif., September 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle inGregory’s Foods Issues Allergy Alert on Undeclared Peanuts in “Bag Full of Cookies” White Chocolate Macadamia Nut Frozen Cookie Dough
Gregory’s Foods, Inc. of Eagan, MN is recalling its 2-pound 8.5-ounce packages of “Bag Full of Cookies” White Chocolate Macadamia Nut frozen cookie dough because some units may contain undeclared Peanut. Frozen Monster Cookie Dough, which contains Peanut, may be packaged in a bag that is labeled asFDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval.Office of New Drugs Custom Medical Queries (OCMQs)
Office of New Drugs Custom Medical Queries (OCMQs) are standardized groupings of similar adverse event terms intended to assist with the identification of potential safety issues during review of adverse event data.Inactive Ingredients Database Download
Data updated through July 2024Endothelin Receptor Antagonist REMS Information
FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.