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FDA invites comment on guidance on meetings with OTC sponsors

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,”...

News

FDA invites comment on guidance on meetings with OTC sponsors

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,”...

News

Meta ban on health-targeting ads will soon restrict clinical trial recruiters

A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting...

News

FDA seeks comments on how to transition approved drug products to device status under Genus

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision&n...

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...

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The U.S. Food and Drug Administration (FDA) recently published the new draft guidance “Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for...

News

FDA offers guidance on clinical trial waivers for investigators at non-U.S. sites

On May 19, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1),” updating ...

News

Federal court limits FDA discretion in “drug” vs. “device” classification

The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either...

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...

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