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

Safety Information For More Than 200 Drugs Posted Ahead Of Drug Watch Site

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA has posted drug-specific safety information for more than 200 products on a Center for Drug Research & Evaluation Research web page

You may also be interested in...



FDA Analysis Suggests Potential Pituitary Tumor Signal For Risperdal

Review of adverse event reporting system of pituitary tumors and antipsychotics shows the “vast majority” of tumors were with risperidone. Further data is needed before the signal would be posted on FDA’s drug safety watch list, the agency says. J&J will analyze the study and other data to determine if further studies are needed.

FDA Analysis Suggests Potential Pituitary Tumor Signal For Risperdal

Review of adverse event reporting system of pituitary tumors and antipsychotics shows the “vast majority” of tumors were with risperidone. Further data is needed before the signal would be posted on FDA’s drug safety watch list, the agency says. J&J will analyze the study and other data to determine if further studies are needed.

Drug Safety Oversight Board Will Require Two-Thirds Majority For Recommendations

FDA's Drug Safety Oversight Board will need a two-thirds majority of a quorum to make recommendations, a Center for Drug Evaluation & Research Manual of Policies & Procedures states

Topics

UsernamePublicRestriction

Register

LL1133546

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