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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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News

HHS offers flexibility on human subjects protection regs during COVID-19 pandemic

On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection...

News

COVID-19’s impact on clinical trials prompts FDA to issue guidance to assist with study conduct
Registered Content

On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance“Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic." The guidance...

News

The global impact of COVID-19 on clinical trials and countermeasure development
Registered Content

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of...

Publications

Just One More Day Compliance Deadline for New ClinicalTrials gov Regulations is Tuesday April 18 2017 Pharma/Biotech Alert

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results...

Hogan Lovells Publications

Ready, Set... Cures Act Expanded Across Policy Deadline Is Almost a Go Pharmaceutical and Biotechnology Alert

As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain...

Hogan Lovells Publications

A "Cure" for Combination Products: 21st Century Cures Act Mandates Greater Transparency of Combination Product Designations Pharmaceutical and Medical Device Alert

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat...

Hogan Lovells Publications

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration Pharmaceutical and Biotechnology Alert

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two ...

Hogan Lovells Publications

Short-fuse compliance deadline for expanded access provision in 21st Century Cures Act Focus on Regulation

Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of...

Hogan Lovells Publications

Much to metabolize: The 21st Century Cures Act introduces numerous changes to FDA’s drug regulatory framework to spur development of new treatments Pharmaceutical and Biotechnology Alert

The 21st Century Cures Act (Cures Act) has become law with measures designed to deliver new cures and treatments to patients. Among these measures are a broad range of changes to the...

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