FDA Call For Pediatric Cough/Cold Input Signals New Rule Is A Long Way Off
This article was originally published in The Tan Sheet
Executive Summary
FDA plans to revise monograph language for over-the-counter pediatric cough/cold products, but the agency is seeking input on some basic data questions first, indicating many steps will be taken before a rule can be finalizedYou may also be interested in...
“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock
Janet Woodcock says FDA expected when the process was launched to complete all monographs by the year 2000, but 25 remain in tentative final monograph status, with a rulemaking required to finalize each one. “The rulemaking process … doesn’t work for getting monographs done in a very timely manner,” she says.
“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock
Janet Woodcock says FDA expected when the process was launched to complete all monographs by the year 2000, but 25 remain in tentative final monograph status, with a rulemaking required to finalize each one. “The rulemaking process … doesn’t work for getting monographs done in a very timely manner,” she says.
AAP Presses FDA To Eliminate OTC Pediatric Combination Products
The American Academy of Pediatrics wants FDA to eliminate OTC combination pediatric cough/cold products.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: