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Comments on draft guidance entitled "Electronic Common Technical Document Specification" requested by FDA in Nov. 28 Federal Register notice.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Second draft guidance defining means for electronically submitting regulatory information to FDA published in Federal Register June 14.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...

J&J Has Big Plans For Robotic Surgery In 2020

The company’s leadership discussed its recent investments in robotic surgery technology during Johnson & Johnson’s 2019 fourth-quarter earnings call on 22 January. The company will provide more information on its robotic surgery platforms at its investors meeting in May in New York.

Study Links Paclitaxel To Lower-Leg Amputations

New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.





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