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

Rx Regulatory Puzzle: FDA’s 2015 Agenda Comes Together Piece By Piece

Executive Summary

Generic drug labeling, drug shortages and compounding will be tackled in regulations in 2015; three documents weave together a picture of FDA’s upcoming actions on pharmaceutical-related rules.

You may also be interested in...



FDA Adverse Event Reporting Reg Offers Few Exceptions

Companies must submit post-market safety reports electronically beginning in June 2015; waivers will be allowed, but they would only be temporary.

National Licensing Standard For Wholesale Distributors Gains Momentum

In the face of counterfeit drug problems and questions over the safety of the nation's drug supply, momentum appears to be building for a national wholesale distributor licensing standard

PhRMA’s Vision For 21st Century Marketing Would Reshape Supplemental NDAs

Five-point plan that calls for FDA to change definition of ‘labeling’ and ‘substantial evidence’ may offer hints as to what the next iteration of 21st Century Cures legislation will offer.

Topics

UsernamePublicRestriction

Register

PS056584

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

Cancel