Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

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
My View
Tags:
Advisory Committees Review Pathway Regulation

Pink Sheet Podcast: Makena Hearing Take-Aways, Industry’s Accelerated Approval Failings, US FDA Claims Enforcement

  • Analysis

Executive Summary

Pink Sheet reporters and editors discuss lessons from the public hearing on the proposed withdrawal of the preterm birth prevention drug Makena, FDA Commissioner Califf’s opinion that industry is not meeting expectations with accelerated approval confirmatory studies, and agency efforts to clarify that staff is paying attention to comparative claims in product ads.

Table

View full table

Topics

Related Companies

Tags:
Advisory Committees Review Pathway Regulation
Latest Headlines

Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy

Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List

Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

See All
UsernamePublicRestriction

Register

PS147201

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

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