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


The Return of Part 11

This article was originally published in The Gold Sheet

Executive Summary

FDA July 7 alerted industry that the agency will soon begin conducting inspections focused on compliance with its March 1997 Part 11 rule on electronic records and electronic signatures

You may also be interested in...

Latest FDA Drug GMP Warning Letters Target CEOs, Contract Manufacturers

Six of FDA's last nine drug GMP warning letters went to contract manufacturing facilities, including firms making OTC drugs and dietary supplements.

CEOs and Contract Manufacturers
Targeted in Latest Warning Letters

FDA sent six of its last nine drug GMP warning letters to contract manufacturing facilities. Most of the letters emphasized corporate accountability, and many went directly to CEOs.

Balancing Innovation And Safety – The US and Australian Medtech Regulatory Systems Compared

Effective medical device regulation supports both safety and innovation needs. This article assesses how well the US FDA and the Australian TGA achieve this balance.




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