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April 24, 2020

Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events

Docket Number: FDA-2009-D-0217 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to assist […]
April 24, 2020

Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

Docket Number: FDA-2016-D-2285 Issued by: Guidance Issuing Office Office of Foods and Veterinary Medicine, Center for Veterinary Medicine Office of Medical Products and Tobacco, Center for […]
April 24, 2020

Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations

Docket Number: FDA-2018-D-1456 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations for the […]
April 24, 2020

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems

 Listen Welcome to the FDA Drug Safety Podcast for health care professionals. On April 24, 2020 FDA announced that we are aware of reports of serious […]
April 24, 2020

Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center – 552431 – 03/31/2020

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name HeeJoo Park, RPh Recipient Title President and CEO, COO, CFO Puget Sound Drug Corporation dba Key Pharmacy […]
April 24, 2020

M9 Biopharmaceutics Classification System-Based Biowaivers

Docket Number: FDA-2018-D-3614 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research Office of Medical Products and Tobacco, […]
April 24, 2020

M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries

Docket Number: FDA-2005-D-0459 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research It is desirable for regulators and […]
April 24, 2020

M4: The CTD — Quality Questions and Answers /Location Issues

Docket Number: FDA-2002-D-0261 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 24, 2020

M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry

Docket Number: FDA-2017-D-5139 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
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