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News

Time’s up: New enforcement era for regenerative medicines begins June 1

On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative...

Hogan Lovells Publications

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...

News

COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....

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

Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. The Ensuring...

News

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the reintroduced Republican-led H.R. 19, the “Lower...

Insights

Practical Implications of the Whistleblowing Directive: Compliance, Data Protection and Employment
Registered Content

There are certain unlawful activities committed by (or within) companies, Public Administrations or other entities, which are very difficult to identify if the closest...

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

Court puts health care providers on notice that illegal kickbacks can trigger significant damages

The United States Court of Appeals for the Fourth Circuit recently affirmed a $114 million judgment in a protracted, and hotly contested, suit filed under the qui tam provisions of the...

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