As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
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Slendid – 09/09/2025
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDetachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System
MedTech/CERENOVUS is removing CEREPAK Detachable Coil Systems due to a higher than expected failure to detach rateHospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.Mellace Family Brands California, Inc. Recalls Wegmans Deluxe Mixed Nuts Unsalted, 34 oz and 11.5 oz Packages Because Of Possible Health Risk
Mellace Family Brands California, Inc. of Warren, OH has issued a recall for Wegmans Deluxe Mixed Nuts Unsalted 34 oz Tubs and Wegmans Deluxe Mixed Nuts Unsalted 11.5 oz bags because they have the potential to be contaminated with SalmonellaFantasy Aphrodisiac Chocolate may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Fantasy Aphrodisiac Chocolate, a product promoted and sold for sexual enhancement on various websites, including gearisle.com, and possibly in some retail stores.Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies