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

‘Industry Failing On Evidence Generation,’ US FDA’s Califf Says Of Accelerated Approvals

 
• By Francesca Bruce

As a “laborious” hearing at the Food & Drug Administration on whether to withdraw the accelerated approval for Covis’s pre-term delivery drug Makena, FDA chief Robert Califf commented that industry is not doing enough to provide the evidence required for the fast-track approval pathway.

FDA Commissioner Robert Califf testifies at House Appropriations Committee hearing
Reform of the accelerated approval pathway will be “considered later this year in one way or another," said FDA chief Califf • Source: Screenshot

The pharmaceutical industry is failing to produce the necessary follow-up studies to maintain accelerated approvals, US Food & Drug Administration Commissioner Robert Califf said at a regulatory affairs conference this week. His comments came as an FDA hearing is underway to determine whether the agency’s accelerated approval for Covis Pharma’s Makena (hydroxyprogesterone caproate or 17-OHPC) should be withdrawn.

Califf has previously said that the main way to improve the accelerated approval pathway is to cut the time between...

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

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

Merck’s Clesrovimab Vote Reflects New ACIP Members’ Skepticism

 
• By Sue Sutter

The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.

Oz Says Big PBMs Have ‘Window’ to Quit Rebate System on Their Own

 
• By Leslie Small

CMS Administrator Mehmet Oz said PBMs may deserve "one last chance" to fix the rebate system before federal regulations and legislation are enacted.

New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

 
• By Sue Sutter

The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.

More from Conferences

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.