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

Temple: FDASIA Directs FDA To Learn To Use Existing Authority

Executive Summary

CDER’s Robert Temple says FDASIA mostly restates existing FDA authority, but also tells the agency it must better communicate what authority it has and how it will use it.

You may also be interested in...



Opioid Bills Could Enhance US FDA Approval, Withdrawal Authority

House opioid package includes ability to deny or withdraw products because of abuse potential, but new Senate package does not, setting up potential conference battle.

Industry Wants A Breakthrough Therapy, Even Without All The Standards

A few requests have gone to FDA for candidates to be named breakthrough therapies and gain access to shorter development programs, but the agency has not established all the program requirements yet.

FDASIA Is Signed, Not That White House Wanted Anyone To Notice

White House sends out short press release as FDA is conducting an unrelated briefing to announce the user fee bill was enacted, surprising stakeholders and generating political questions.

Related Content

Topics

UsernamePublicRestriction

Register

PS054988

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