1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials
  4. >>Real-World Evidence

US FDA’s Amy Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

 
• By Sue Sutter

After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop their own momentum. Abernethy, who also serves as the agency’s acting chief information officer, worked to modernize the FDA’s information technology infrastructure and data capabilities while also exploring ways to confidently use real-world data to support regulatory decision-making.

Amy Abernethy 2020
Amy Abernethy will depart the FDA in April after more than two years as principal deputy commissioner. • Source: FDA

Amy Abernethy’s decision to leave the US Food and Drug Administration after just more than two years boiled down to two reasons: wanting to see initiatives she helped establish move forward on their own, and having high confidence in the current acting commissioner.

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 Real-World Evidence

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
• By Eliza Slawther

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

Canada’s New Rare Disease Registry Guidance To Assist Regulatory And HTA Decision Making

 
• By Francesca Bruce

Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.

Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
• By Sue Sutter

A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

More from Clinical Trials

EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.