US FDA To Publish Own Datasets In Latest Signal Of Enhanced Transparency

19 Sep 2017

• By Michael Cipriano

Adverse event reporting data will also be more readily available, Commissioner Scott Gottlieb says.

The US FDA is looking to routinely publish clinical data used in regulatory decision making along with adverse event reporting data, in what appears to be just the latest effort of Commissioner Scott Gottlieb's high profile effort to enhance transparency at the agency.

Speaking at the POLITICO Pro Summit Sept. 14, Gottlieb explained that sometimes FDA develops its own datasets based on submitted datasets from sponsors to help the agency make its own...

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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

20 May 2025

• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

20 May 2025

• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.