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

FDA Science Board's Report: Legislative Negotiating Tactic, Or Just Whining For Money?

 
• By Brenda Sandburg

21st Century Cures criticized by FDA advisors for unfunded mandates, but legislation also represents best near-term prospect for reforms of the kind the report envisions.

FDA’s Science Board has offered a slew of recommendations to strengthen the agency's capabilities, many of which could find support from Capitol Hill leadership. However, the report's negative tone toward the major ongoing congressional reform effort suggests that the document could serve as much a legislative negotiating tactic as a blueprint for the agency's internal efforts.

Indeed, for a report that nominally intends to advise FDA on how it should approach scientific challenges, there are few...

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

Non-Opioid Analgesics Guidance On Chronic Pain: One Trial Plus Confirmatory Evidence May Be Enough

 
• By Laura Helbling

Alternative therapies designed to avoid, eliminate, or reduce the use of opioids may be eligible for Breakthrough Therapy Designation or Priority Review, the US FDA draft guidance says.

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.

More from North America

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.

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.