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First-Cycle Approval Rate Already High; Can PDUFA V Actually Boost It?

 
• By Derrick Gingery

FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.

FDA already may be nearing the peak of its ability to approve applications during the first review cycle, less than a year into use of a new review system intended for that purpose.

The agency’s first-cycle approval rate, which measures the portion of submitted applications successfully cleared before their first user fee goal...

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More from United States

Under Trump, Antitrust Regulators May Be More Divestiture Friendly

 
• By Tim Casey

The Trump Administration may differ from the Biden Administration in some areas of health care antitrust enforcement, but experts said some Biden-era priorities may be maintained.

US FDA Plan To Limit Studies Eligible For Pediatric Exclusivity Criticized By Industry, NORD

 
• By Sue Sutter

The agency’s proposal to award six-month pediatric exclusivity only for studies beyond those required under the Pediatric Research Equity Act will weaken the incentive and result in less research for pediatric uses, stakeholders said.

‘Chubby Labels?’: Generic Entresto Approval Was Lawful, D.C. Appeals Court Finds

 
• By Dean Rudge

MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.

CDC Should Boost Vaccine Monitoring Transparency, Communication - National Academies Report

 
• By Sue Sutter

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.

More from North America

Galderma’s Post Hoc Analysis Supports Nemluvio Claims But Clearer Disclosures Needed, NAD Says

 
• By Cathy Kelly

Claims for the dermatological appearing on websites and social media were challenged by Dupixent marketer Sanofi. Galderma said it would comply with the National Advertising Division’s recommendations, a move that underscores the challenging times for DTC advertisers.

Former CBER Director Peter Marks Brings Genetic Medicines Street Cred To Lilly

 
• By Jessica Merrill

FDA’s former CBER director is joining industry as senior VP of molecule discovery and head, infectious disease at Eli Lilly.

Oz Hints That Medicare Action On GLP-1s And Weight Loss Coming

 
• By Sarah Karlin-Smith

CMS Administrator Oz punted on a GLP-1 question in an interview, suggesting it was because his agency will be acting soon.