1. Pink Sheet
  2. >>Compliance
  3. >>Marketing & Advertising

Biopharma Wins Reprieve On US FDA 'Intended Use' Rule

 
• By Brenda Sandburg

In response to MIWG petition, agency delays by one year implementation of final rule on what activity is considered evidence of a manufacturer's intended use of a product.

FDASignBldg21Entrance_1200x675

Industry groups convinced FDA to reconsider its final rule for assessing a manufacturer's "intended use" of a product. The agency is going a step further and seeking public comments on their requested revisions to the rule, including that only a manufacturer's promotional statements be considered evidence of intended use that should be included in product labeling.

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 Marketing & Advertising

More from Compliance

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA