HBW Insight 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.

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

Pre-Announced Drug Inspections To Continue At District Offices' Discretion

This article was originally published in The Tan Sheet

Executive Summary

FDA's pre-announced inspection program for drugs will continue at the discretion of district office management, a notice in the Jan. 4 Federal Register states.

You may also be interested in...



FDA inspections

Pre-announced inspection program receives "high marks" from CHPA members and has "helped streamline routine inspections and...enhanced the goodwill and cooperation of FDA and industry," trade association says in Oct. 30 letter urging agency's Office of Regulatory Affairs to retain the program for drug manufacturing facilities. FDA expanded the system from devices to drugs and biologics in 1999 as a three-faceted pilot program - pre-announced inspections, annotated 483 inspection reports and formal notification of positive inspection results. ORA currently is evaluating the program's status as part of its resource utilization review, the agency says

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

In Brief

Combe sells most of its OTC brands

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS131379

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