IND Safety Analysis Requires Broader Unblinding Of Reports, FDA Advises
This article was originally published in The Pink Sheet Daily
Sponsors should create safety assessment committees, draft guidance recommends.
You may also be interested in...
IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body
US FDA officials, drug sponsors discussing creation of library of adverse event rates.
The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.
Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.