Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).
Similar Posts
Chengdu Brilliant Biopharmaceutical Co., Ltd. – 711330 – 09/11/2025
CGMP/Finished Pharmaceuticals/AdulteratedWegmans Recalls Locatelli Grated Pecorino Romano Cheese Due to Possible Health Risk
Wegmans Food Markets is recalling Locatelli Grated Pecorino Romano Cheese with Wegmans’ scale labels due to the potential presence of Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immuneInfusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue
Infusion pumps released with incorrect software can experience unexpected performance problems, including issues with essential functions and risk measures.Sprout Organics Voluntarily Recalls One Lot of Sweet Potato Apple and Spinach Due to Possible Health Risk
Sprout Organics has initiated a voluntary recall of one lot of Sprout Organics® Sweet Potato Apple and Spinach because it may contain elevated levels of lead.FDA Publishes Filing Checklists to Prevent Submission Delays
The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable.Missouri Analytical Laboratories Inc – 615319 – 10/09/2024
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated