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


BPCA Adverse Event Reports To Be Presented According To Three-Tier System

Executive Summary

FDA has developed a three-tier system for its presentations of pediatric drug adverse event reports to its Pediatric Advisory Committee, as mandated by the Best Pharmaceuticals for Children Act

You may also be interested in...

Concerta Adverse Events Update On “Drug Watch” Web Site Advised By Cmte.

FDA should consider posting concerns about psychiatric and cardiovascular adverse events with Johnson & Johnson's Concerta and other methylphenidate products on the agency's upcoming "Drug Watch" website, members of FDA's Pediatric Advisory Committee said

Ortho Tri-Cyclen Pediatric Precaution Data Will Be Added To Label

Ortho-McNeil is changing labeling for Ortho Tri-Cyclen to include information from its pediatric exclusivity study showing lack of significant effect on low mineral bone density in anorexic adolescent females

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011





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