US FDA Patient Medication Information Proposed Rule May Be Coming Soon

A proposal for a new form of patient labeling, which has been in the works for decades, may finally be coming to fruition despite the FDA missing a December 2022 target date listed in HHS’ semi-annual regulatory agenda.

Sunrise over ocean
Decades in the making, the PMI proposed rule may be close on the horizon. • Source: Shutterstock

If the US Food and Drug Administration’s latest regulatory agenda is to be believed, the long-awaited proposed rule on Patient Medication Information labeling may be imminent.

The Health and Human Services Department’s semi-annual regulatory agenda, which will publish in the Federal Register on 22 February,...

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

More from Post-Marketing Regulation & Studies

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By 

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By 

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By 

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

More from Product Reviews

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 

FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?

PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 

PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.