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

User Fees For Biomarker Qualification Might Improve Study Designs

Executive Summary

Despite Bob Temple’s assurance that draft enrichment guidance allows companies to exclude biomarker-negative patients, industry asks FDA for more guidance on when they can safely say a biomarker is discriminatory.

You may also be interested in...



On The Trail Of Specifics: Industry Critiques Draft Enrichment Guidance

When and how to incorporate marker-negative patients into enriched clinical trials remains undefined for drug companies, which appear accepting of limited indications for marker-positive patients.

Hahn Says COVID Vaccine Review Could Take Months As Trump Floats Rejecting New EUA Guidance

Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.

Six Pharma CEOs To Testify In House as Democrats, Trump Compete For Attention On Drug Pricing

While neither party is likely to make any big policy changes this year, the action from both sides of the aisle indicates politicians still see going after pharma as a winning issue with voters even as polls show voters are focused elsewhere. 

Topics

Related Companies

UsernamePublicRestriction

Register

MT142464

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