3. >>Clinical Trials

Clinical Trial Reporting: US FDA To Step Up Listings, But Not Fines, After Petition

 
• By Brenda Sandburg

Following request by Universities Allied for Essential Medicines, FDA creates a public dashboard of pre-notices of noncompliance on registering trials and submitting results to ClinicalTrials.gov. The agency denies request to impose civil penalties on those who fail to comply, citing its discretion.

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FDA agrees to make pre-notices of noncompliance with clinical trial reporting requirements public • Source: Shutterstock

The US Food and Drug Administration quietly implemented a citizen petition request to make its pre-notices of noncompliance with ClinicalTrials.gov reporting requirements publicly available. But the agency denied calls for it to beef up enforcement and impose civil monetary penalties.

Key Takeaways
  • FDA’s petition response is a quiet acknowledgement that it could be doing more to encourage ClinicalTrials.gov listings.

Universities Allied for Essential Medicines North America (UAEM), an international nonprofit promoting health equity and access to medicines, submitted the...

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UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

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.

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New Drug Procurement Rules Aim To Drive Pharma Investment In Mexico

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.