1. Pink Sheet
  3. >>Clinical Trials

New COVID Therapeutic Development Hitting Regulatory Wall At US FDA

 
• By Sarah Karlin-Smith

FDA trial design criteria pose challenges for new COVID therapeutic development, frustrating companies and NIH and prompting a tense meeting earlier this summer, according to audio obtained by the Pink Sheet.

covid therapies hitting FDA wall
Drug companies are struggling to agree with FDA on pivotal trial designs for new COVID therapeutics • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

There’s little clarity from regulators on viable paths forward for new COVID-19 therapeutics, leading to frustration among drug developers who see unfilled medical need as the SARS-CoV-2 pandemic lingers but uncertainty about whether the US Food and Drug Administration will greenlight their pivotal studies.

The current challenges are in part due to the pharmaceutical industry’s COVID-19 successes

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 Clinical Trials

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

More from R&D