Coronavirus Sponsors Should Get Responses To Regulatory Requests Within One Day, US FDA Says

As part of the new Coronavirus Treatment Acceleration Program, FDA staff also are being reassigned to handle investigational therapy requests faster.

3D_Coronavirus
The FDA moved staff to review divisions in order process coronavirus therapy requests faster. • Source: Shutterstock

The US Food and Drug Administration is looking to respond to inquiries from sponsor about new potential coronavirus therapeutics within a day.

The Coronavirus Treatment Acceleration Program (CTAP) was announced 31 March as a system to help speed development of new treatments that could fight the coronavirus pandemic

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 Product Reviews

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Recent and Upcoming FDA Advisory Committee Meetings

 
• By 

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

US FDA Advisory Committee Misperceptions Abound … At HHS

 

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

More from Pink Sheet

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.