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

FDA’s Overhaul Of GMP Oversight Will Include Numerous Targeted Guidances

Executive Summary

FDA is developing an ad hoc guidance process for manufacturing issues through which it will issue short recommendations based on specific circumstances

You may also be interested in...



NDA Reviews Will Be Risk-Based Under FDA Good Manufacturing Initiative

The Center for Drug Evaluation & Research will apply a risk-based approach in considering manufacturing issues in reviewing NDAs, Office of Compliance Director David Horowitz said

NDA Reviews Will Be Risk-Based Under FDA Good Manufacturing Initiative

The Center for Drug Evaluation & Research will apply a risk-based approach in considering manufacturing issues in reviewing NDAs, Office of Compliance Director David Horowitz said

FDA Dispute Resolution Process Should Be Less Structured, Merck Exec Says

Industry wants FDA's dispute resolution process to allow for less structured interaction during the appeals process, Merck Manufacturing Quality Assurance Director David Haggard said

Related Content

UsernamePublicRestriction

Register

LL1133951

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