FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts

By Kristin McDougall, Workstream Lead, Transparency & Disclosure Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s ...

Read More

EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update - Major Changes Several major changes are noted in this “Summary of Changes” document, including: Cl ...

Read More

Implications of FDA’s Decision to Issue Fines for Failing to Submit Clinical Trial Data

The U.S. Food and Drug Administration (FDA) issued a draft guidance last week proposing levying heavy fines on pharmaceutical companies and contract research organizations (CROs) that do not post clinical trial results online. FDA said in the draft guidance, titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” that failure to register trials or submit results to ClinicalTri ...

Read More

We Checked EPARs for Personal Data and Found It

By Kristin McDougall, Work Stream Lead, Transparency & Disclosure What started as research on a European public assessment report (EPAR) on the European Medicines Agency (EMA) website for a sponsor, quickly turned in to a wide spread transparency and disclosure health and wellness check. With the General Data Protection Regulation (GDPR) in effect, knowing exactly what documents are posted pu ...

Read More

EMA Policy 43: Revised Policy on Access to Documents

By Kristin McDougall, Work Stream Lead, Transparency & Disclosure The European Medicines Agency (EMA) recently placed a new notification on its website revising who can request access to unpublished documents under the scope of Policy 43. EMA Policy 43 pertains to the legal right of access to documents that were sent to the EMA for now-approved medicinal products for human and veterinary use. ...

Read More
1 2