Clinical trial transparency in the pharmaceutical industry is continually evolving, and to stay on top of the news, TrialAssure brings a bi-weekly round-up of some of the key stories. Select recent and relevant stories are as follows:
Judge rules decade worth of unreported clinical trial data must be published – BioSpace
A U.S. federal judge recently ruled that a decade’s worth of clinical trial data from drug companies, universities, and other organizations must be published. A former FDA associate commissioner filed a lawsuit over the lax reporting requirements and a lack of enforcement of transparency regulations on behalf of federal agencies.
Read Alex Keown’s piece here
FDA in brief: FDA enhances purple book to support transparency in biosimilars – U.S. Food & Drug Administration
The U.S. Food and Drug Administration (FDA) announced that it is upgrading the Database of FDA-Licensed Biological Products, otherwise known as the “Purple Book.” The changes will occur in phases and seek to expand the dataset and information about certain biological products.
Get all the updates via the FDA newsroom
Registration open for modernization of ClinicalTrials.gov public meeting—ClinicalTrials.gov
In an effort to modernize ClinicalTrials.gov, the National Library of Medicine (NLM) is hosting a public meeting to obtain public input and improve user experience on the updated website. The meeting is scheduled for April 30, 2020 on the National Institutes of Health (NIH) campus in Bethesda, Maryland.
View the ClinicalTrials.gov news page for all the updates