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FDA warns over use of robotically-assisted surgical devices

Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of...

News

FDA leads global work on continuous manufacturing approaches to up quality, supply chain resilience

Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug...

News

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its...

News

PhRMA responds: Code on Interactions with HCPs updated following fraud alert on speaker programs

On August 6, Pharmaceutical Research and Manufacturers of America (PhRMA) released an updated and enhanced version of its voluntary Code on Interactions with Health Care Professionals...

News

After a long and winding road, FDA finalizes much-debated “intended use” rule

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...

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

What health systems should know about President Biden’s Executive Order Promoting Competition

On 9 July 2021, President Biden signed an Executive Order on Promoting Competition in the American Economy (“EO”) that takes aim, in part, at the healthcare industry. Although...

News

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace...

Insights

New FDA guidance lays out clinical trial sponsor safety reporting requirements
Registered Content

The U.S. Food and Drug Administration (FDA) recently published the new draft guidance “Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for...

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