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

GAO Chides FDA For Prioritizing Foreign Inspections Based On Pre-approval Concerns

Executive Summary

The Government Accountability Office’s latest assessment of FDA’s foreign drug inspections program takes the agency to task for failing to implement a new prioritization scheme that GAO recommended two years ago.

You may also be interested in...



FDASIA Study Mandates Focus On Performance, But Could Slow Reviews

Advocates for the agency worry that while each of the performance assessments seems reasonable individually, together the reports could burden staff to the point of pulling some from application reviews or other tasks to help complete them.

FDA Ups Foreign Inspections In FY ’07; Visits 11% Of Foreign Establishments

FDA inspected more foreign drug establishments in fiscal 2007 than in each of the five previous years, but visited less than 11 percent of such facilities, the Government Accountability Office estimates in a report released Oct. 22

Postmarketing Safety Gets Closer Focus In Latest US FDA Drugs Center Reorganization

Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.

Topics

UsernamePublicRestriction

Register

ID1132298

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