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


International Conference on Harmonization

This article was originally published in The Tan Sheet

Executive Summary

Comments on draft guidance entitled "Electronic Common Technical Document Specification" requested by FDA in Nov. 28 Federal Register notice. Document outlines means for electronically submitting regulatory information to agency in way that will "facilitate [its] creation, review, life cycle management and archiving." Comments are due within 90 days...

You may also be interested in...

International Conference on Harmonization

Second draft guidance defining means for electronically submitting regulatory information to FDA published in Federal Register June 14. Guidance includes changes based on comments on first draft, which was published Nov. 28 (1"The Tan Sheet" Dec. 3, 2001, p. 2). Second draft is clearer, has complete glossary of terms, doubles maximum length of a file name to 64 characters, FDA says. Separate guidance, entitled "Q1E Evaluation of Stability Data" and published same day, should instruct on "how to use stability propose a retest period for the drug substance and a shelf life for the drug product." Comments on both are due Aug. 1...

Inovio Confirms Frontrunner Status In COVID-19 Vaccine Race, But Can It Prove Skeptics Wrong?

Its ‘virus chasing’ habits has given Inovio a bad reputation. But with backing from CEPI and Bill Gates, it has a chance to prove the doubters wrong.

Global Pharma Guidance Tracker – March 2020

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.





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