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

FDA Explains How Generic Firms Will Self-Identify Facilities Under New User Fee Program

 
• By Derrick Gingery

Guidance on meeting the new self-identification requirement is one of several GDUFA-related announcements issued by FDA Aug. 22. The agency will hold a public meeting Sept. 21 to solicit comments on user fee program implementation issues.

Generic drug manufacturers will find a familiar system for facility reporting that should limit the additional burden of meeting the new ANDA user fee program’s self-identification requirement.

In an Aug. 22 notice, FDA announced the release of a guidance outlining how the self-identification system will function as...

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

340B Reform Advocates Hail CBO Report, But ‘Scoreable’ Savings Still In Doubt

 
• By Michael McCaughan

The 340B program increases federal health care costs by encouraging the use of costlier medications, the Congressional Budget Office said. But the agency also did not provide a specific estimate of the impact.

Stealth’s Forzinity Accelerated Approval Shows US FDA Confirmatory Trial Status Flexibility

 
• By Sue Sutter

Stealth has until March 2026 to begin enrolling its confirmatory trial for its Barth syndrome drug elamipretide, marking a rare instance where a novel drug received accelerated approval even though the required postmarketing study was not underway.

ACIP Weakened COVID-19 Vaccine Advice, But Less Than Rhetoric May Suggest

 
• By Sarah Karlin-Smith

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 
• By Bridget Silverman

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.

More from North America

US FDA Appears To Be Managing MAHA Well By Feeding Instead Of Receiving Priorities

 
• By Ramsey Baghdadi

The newly issued Make America Healthy Again strategy report suggests that FDA leaders are doing a good job of feeding ideas to the Trump Administration, rather than having the agency agenda dictated from above.

Stakeholders Warn Medicare Payment Proposals For Cell, Gene Therapy Could Hamper Access

 
• By Cathy Kelly

CMS proposals would reduce Medicare payments for cell and gene therapy manufacturing and preparation, which will further disincentivize outpatient or community-based treatment, advocates and sponsors said.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.