FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active pharmaceutical ingredients (APIs), used to compound drugs. The agency urges compounders to know your bulks supplier and know if they are testing the drugs before you purchase bu
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CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/MisbrandedMeetings, Conferences, & Workshops | Drugs
Meetings, conferences, and workshops sponsored or co-sponsored by Center for Drug Evaluation and Research.FDA approves drug to improve functional capacity and symptoms in adults with rare inherited heart condition
The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.White Castle Frozen Food Division Recalls Frozen 4-Count Cartons of Original Sliders Due to Undeclared Milk and Soy
COLUMBUS, Ohio — White Castle Frozen Food Division has initiated a recall of 1,021 cases of its retail frozen 4-count cartons of Original Sliders due to undeclared milk and soy. The carton may contain Jalapeño Cheese Sliders. Jalapeño Cheese Sliders contain milk and soy, allergens that are not on th2024 First Generic Drug Approvals
2024 First Generic Drug ApprovalsMeeting Presentations | Drugs
Meeting Presentations. CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users fees, to drug advertising and marketing, to genomics, to over-the-co