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

Gilead’s REMS Resubmission Delays FDA Action On Truvada For PrEP

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA extends the user fee deadline for the supplemental indication of HIV pre-exposure prophylaxis to Sept. 14. Although Gilead is not saying what changes it made to the Risk Evaluation and Mitigation Strategy, FDA advisory committee members had recommended making prescriber education mandatory and linking prescribing to documentation of a negative HIV test.

You may also be interested in...



Two Indications, One REMS: FDA Panel Debates Restricted Access For Truvada In PrEP

FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.

ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations

The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.

ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations

The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134420

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