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March 28, 2022

Complex Innovative Trial Design Meeting Program

On this page As displayed in the Federal Register notice on August 29, 2018, FDA is conducting a Complex Innovative Trial Design (CID) Pilot Meeting Program […]
March 28, 2022

Applied Biological Laboratories Inc. – 627062 – 03/24/2022

Product: Drugs Recipient: Recipient Name Mr. Michael Latefi Applied Biological Laboratories Inc. 760 Parkside Ave., 317Brooklyn, NY 11226United States [email protected] Issuing Office: Center for Drug Evaluation […]
March 28, 2022

Iodine Products Inc – 628296 – 03/25/2022

Product: Drugs Recipient: Recipient Name Gene Rosov Iodine Products Inc 8025 SW 63rd PlaceSo. Miami, FL 33143United States [email protected] Issuing Office: Center for Drug Evaluation and […]
March 25, 2022

FDA Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging

The U.S. Food and Drug Administration (FDA) is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media […]
March 24, 2022

Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL, Unit Dose Cups, Due to Microbial Contamination

Summary Company Announcement Date: March 24, 2022 FDA Publish Date: March 24, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial Contamination Company Name: […]
March 24, 2022

Frequently Asked Questions on Potassium Iodide (KI)

In December 2001, the Food and Drug Administration (FDA) issued a final Guidance on Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies) (PDF – 40 […]
March 23, 2022

FDA approves Pluvicto for metastatic castration-resistant prostate cancer

On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) for the […]
March 23, 2022

Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
March 22, 2022

Pfizer Voluntary Nationwide Recall of Lots of ACCURETICTM (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-NitrosoQuinapril Content

Summary Company Announcement Date: March 22, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a nitrosamine, […]
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