Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

An Ex-Commissioner’s Bleak Take On The State Of Biopharma Innovation

Executive Summary

Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.

You may also be interested in...



Big Tech Helping US FDA With Sentinel Expansion

Amazon, Microsoft, IBM among those helping build new operations and innovation centers for the US FDA's safety surveillance system.

Data Standards: Technical ‘Postmortem’ Could Clarify US FDA Preferences, Industry Says

Feedback on application-specific data submission issues that vexed the agency but were not onerous enough to warrant a refuse-to-file letter would help inform future filings and reduce variation across sponsors, industry representatives say at meeting on analytical data standards.

Real World Evidence: ‘Hot Topic’ At US FDA, But Not On Front Burner

Officials are enthusiastic about the possibility of ‘real world evidence’ supporting the regulatory process – but are also eager to tamp down expectations (or fears) that it will make a big difference any time soon.

Topics

UsernamePublicRestriction

Register

PS125544

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel