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Prescription Drugs Medical Devices Drug Compounding

Gardner Law

FDA Issues Numerous Warning Letters

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The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2019 #2

BakerHostetler on

Sharpless Begins as FDA Acting Commissioner – On April 5, Norman E. “Ned” Sharpless, M.D., became the acting commissioner of the FDA. Previously he was the director of the National Cancer Institute....more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - February 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA Notes Increased Concerns About Use of Kratom – As the number of reports of poisonings related to the use of kratom increases, Commissioner Gottlieb tweeted, “Kratom is an opioid. #FDA...more

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