FDA - Pharma Warning Letters and Notice of Violation Letters

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Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:

"These letters are supplied by the CDER Freedom of  Information Office (FOI).  This page only covers letters issued by Headquarters and the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications).  For District Office warning letters, please see the Main FDA FOI Warning Letters Page.

Some of the letters have been redacted or edited to remove confidential information.  Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. "

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FDA Warns of CT Scan Radiation Overdoses

This KWTX news article reports a hospital's problem with CT brain scan radiation overexposure, FDA Warns Hospitals About CT Brain Scan Radiation. The excessive dose problem was identified when a patient reported hair loss after a scan. The end result, the FDA has posted a notification, Safety Investigation of CT Brain Perfusion Scans: Initial Notification. 

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FDA Publishes Rulemaking Histories For OTC Drugs

If you're in the Over-The-Counter (OTC), non-prescription drug business, then this FDA collection might be of some interest to you: Rulemaking History for Nonprescription Products: Drug Category List. The Over-the-Counter (OTC) drug category collection contains Federal Register notices organized by therapeutic category subtopics. Each child collection links to therapeutic category pages organized chronologically. Pretty nice. For example, you can scan the Federal Register history for something like, Hair Growth and Loss, Male Genital Desensitizers, or Weight Control. 

Related Posts: FDA Warning - Anesthetics On Skin Can Harm FDA Alert - Bowel Cleanser Warning Cold Meds For Kids - The FDA Weighs In Again 

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