This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
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CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.Walgreen Company – 662158 – 09/12/2023
Failure to Register and ListCSL Behring – 716297 – 09/09/2025
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Information for Health Care Professionals | Drugs
Drug Information for Health Care Professionals, including drug labeling and safety information.Middlefield Original Cheese Co-Op Recalls Organic Gouda, Colored Cheddar, Mozzarella/Provolone, Pepper Jack, Swiss, Dilly Pickle Cheese and Monterey Jack Due to Possible Listeria Monocytogenes Contamination
Middlefield, OH 9/5/25 – The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling one lot of Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles in 6 oz. and 1.25 lb. packages, one lot of Organic Gouda Cheese in 8 oz. packages, and specific lots of Mozzarella/PPatient Listening Session Summaries
Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.