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FDA
HHS OIG Releases Report on Effectiveness of REMS
In late September 2020, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released a…
OPDP Issues Third Enforcement Letter of 2020
On August 31, 2020, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued the…
OPDP Sends First Untitled Letter of 2020
This year has been a very slow year for enforcement letters from the United States Food and Drug Administration (FDA) Office of…
FDA Releases COVID-19 Guidance on Drug Sample Distribution Requirements
Recently, the United States Food and Drug Administration (FDA) issued a policy guidance outlining the agency’s enforcement of drug…
OPDP Enforcement Slowing to a Crawl?
We have previously written about the downward slope of enforcement letters from the United States Food and Drug Administration…
FDA Proposes New Right to Try Requirements Including Annual Reports from…
In a recently proposed rule, the FDA proposed Right to Try law requirements. The agency will require drug manufacturers to issue…
FDA Abandons DRD Proposal
Earlier this year, the United States Food and Drug Administration (FDA) announced it would no longer pursue a proposed regulatory…
Indivior Agrees to FTC Settlement Over Suboxone Claims
Recently, Indivior, Inc. agreed to pay $10 million to settle allegations by Federal Trade Commission (FTC) that it violated…
Hahn Announces Some FDA Changes to Be Made Permanent
The United States Food and Drug Administration (FDA) made several changes in response to the COVID-19 pandemic, and now FDA…
FDA Responds to Clinical Trials & Part 11 Compliance During COVID-19
The U.S. Food and Drug Administration (FDA) issued updated guidance on how to conduct clinical trials during the COVID-19 public…