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January 5, 2023

Should You Give Kids Medicine for Coughs and Colds?

Image Avoid using imported medicines, especially for children. Medications from other countries might not have been evaluated for safety and effectiveness. These products may be addictive […]
January 5, 2023

Regulatory Pharmaceutical Fellowship Program

Medication Safety – 1 position Two-Year Medication Error Pharmacovigilance and Risk Management Fellowship provided by Butler University Fellowship dates: July 1, 2023 – June 30, 2025 Four months […]
January 4, 2023

REMS Document Technical Conformance Guide

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This Risk Evaluation and Mitigation Strategy (REMS) Document Technical […]
January 4, 2023

Pediatric Exclusivity Granted

Drugs to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies […]
January 4, 2023

Format and Content of a REMS Document Guidance for Industry

Docket Number: FDA-2009-D-0461 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides updated recommendations for […]
January 3, 2023

Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation

Mifeprex (mifepristone) and its generic Mifepristone Tablets, 200 mg (collectively mifepristone) are approved, in a regimen with misoprostol, to end an intrauterine pregnancy through ten weeks […]
January 3, 2023

Overview: Clinical Pharmacology Considerations for Neonatal Studies – 02/15/2023

On This Page Date: February 15, 2023 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR In […]
January 3, 2023

globalpharmacyplus.com – 631427 – 12/27/2022

Product: Drugs Recipient: globalpharmacyplus.com Canada Issuing Office: United States FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded […]
January 3, 2023

Superior Glove Works, Ltd. – 641100 – 12/16/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Tony Geng Recipient Title Owner and President Superior Glove Works, Ltd. Acton ON L7J 1S1Canada Issuing […]
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