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Gene Therapy Platforms May Require Less Preclinical Data, Gottlieb Says

 
• By Brenda Sandburg

US FDA's preclinical policies should be 'more closely matched to the complexion of modern technologies,' commissioner explains.

FDA entrance sign 2016

US FDA Commissioner Scott Gottlieb said the agency is developing new policies for preclinical development of products involving new technology platforms, whereby certain second entry therapies could require less pre-clinical data.

"We're going to be taking other new steps to make sure that our policies governing early, pre-clinical science are more...

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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.

More from R&D

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.