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Life Sciences Data Management Food and Drug Administration (FDA)

Burr & Forman

FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees

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The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical trials. Originally...more

Jones Day

Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

Jones Day on

On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 # 6

Hogan Lovells on

In Washington - The House of Representatives returns from recess this week to join the Senate colleagues for the final work period before they adjourn in mid-October for the November elections. The likelihood of a deal on...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – August 2020 # 17

Hogan Lovells on

In Washington - The Republican National Convention kicked off Monday night and centered around President Donald Trump’s response to the coronavirus pandemic. ...more

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

Morgan Lewis on

The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

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