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FDA's Temple of Wisdom: The Dean of Drug Development

 
• By Ramsey Baghdadi

FDA will have new money and new authority before the year is out. But translating the new drug safety reforms into practice will be the responsibility of some old hands, including the Robert Temple, the dean of FDA's drug review group. The question drug companies should have: What is he thinking?

By Ramsey Baghdadi

In February, during a Congressional hearing focusing on the Food & Drug Administration’s approval of Sanofi-Aventis ’ antibiotic Ketek, a panel of ex-FDA witnesses did not have many good

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More from Platform Technologies

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

UK MHRA Consults On The Way For Personalized mRNA Cancer Therapies

 
• By Eliza Slawther

The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.

‘Ambitious Platform’ Among EU Proposals For Increasing mHealth Data Use In Regulatory Decision-Making

 
• By Neena Brizmohun

mHealth data generated by smartphones and wearables show potential for enhancing the clinical evidence used in regulatory decision-making, but there are “notable challenges” that may hinder the use of such data, EU regulators say.

US FDA Not Ready For Sponsors Citing Others’ Platforms Yet, Marks Says

 
• By Derrick Gingery

Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.

More from Advanced Technologies

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

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.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.