1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

USP Suggests “Group Monographs” To Augment OTC Drug Review

 
• By Malcolm Spicer

Compiling drug product monographs, “particularly for the ever-changing” OTC monographs, “has proved daunting,” USP says in comments to FDA. The organization says “group monographs” would be defined by applicability to assay and impurity procedures and those for identity.

The U.S. Pharmacopeia suggests using “group monographs” defined by testing procedures to augment FDA’s current OTC monograph system defined by drug indications and the testing organization’s own drug ingredient compendium.

USP’s recommendation, in its comment to FDA on improving the agency’s over-the-counter drug review process, is similar to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

More from North America

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By Cathy Kelly

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.