FDA Sets One-Month Target For Post-Marketing Requirement Discussions In Final Guidance
This article was originally published in The Pink Sheet Daily
Executive Summary
Industry wanted FDA to impose a detailed set of internal requirements on itself before imposing PMRs, but in final guidance on the subject the agency does not do so.
You may also be interested in...
Merck’s Postmarketing Study Delays Prompt FDA To Unsheathe New Enforcement Power
Januvia and Janumet are misbranded, FDA tells Merck in a warning letter noting that rodent safety studies for the sitagliptin diabetes drugs were 20 months behind schedule. The letter marks the first time FDA has used its FDAAA powers to take enforcement action against a pharma company for such a delay.
FDAAA Post-Marketing Requirements Growing As Commitments Decline
Safety studies imposed under FDA Amendments Act authorities are a growing portion of sponsors’ post-approval study burden, while post-marketing commitments are declining, according to the latest FDA annual report on the status of post-marketing requirements and commitments.
FDAAA Post-Marketing Requirements Growing As Commitments Decline
Safety studies imposed under FDA Amendments Act authorities are a growing portion of sponsors’ post-approval study burden, while post-marketing commitments are declining, according to the latest FDA annual report on the status of post-marketing requirements and commitments.