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News

First company receives FDA violation notice for ClinicalTrials.gov submission omission

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results...

News

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring...

News

FDA ups OTC monograph facility fees 45% for FY 2021, with exemption for some hand sanitizer makers

In today’s Federal Register, the U.S. Food and Drug Administration (FDA) updated and reissued the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2021....

Hogan Lovells Publications

Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...

News

2020 OPDP Wrap-up: FDA monitoring drug manufacturers’ use of online communication platforms

In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for...

News

HHS forces FDA to withdraw notice for OTC user fees and creates new exemptions

On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection efforts” related to the...

News

Final FDA combination product guidance encourages application-based feedback pathways

The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it...

News

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations...

News

A step in the right direction: Encouraging diversity in clinical trial populations

On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria,...

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