US FDA’s Califf Says Publishing Complete Response Letters Could Help Fight Misinformation

But the commissioner also said proponents of releasing CRs may be making too much of the idea, because there are few CRs actually issued.

File cabinet
FDA Commissioner Robert Califf wants to figure a way to provide more and correct information about complete response letters. • Source: Alamy

Commissioner Robert Califf believes releasing information related to US Food and Drug Administration complete response letters may not be as advantageous as proponents expect, but could be an opportunity to fight misinformation.

Califf said 31 March during the Stat Breakthrough Science Summit that there are only a few complete response letters actually issued

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 Complete Response Letters

More from Product Reviews

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By 

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.