Pink Sheet is part of the Business Intelligence Division 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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
Advertising
Report Store
UsernamePublicRestriction
Tags:
Risk Management Generic Drugs Pricing Debate

REMS Website Will Name, Not Shame, Potential Abusers – Gottlieb

  • Analysis

Executive Summary

US FDA will list number of inquiries about acquiring samples for generic drug development, and also whether FDA sends letters to brand companies telling them it is safe to provide the generic sponsor with the samples. 
Table

View full table

Advertisement

Related Content

Pink Sheet
REMS Abuse Website: All Sizzle, No Steak?
Pink Sheet
Generic Company Disclosure Could Be A 'Speedbump' Against Misuse Of US FDA Access Inquiry List
Pink Sheet
Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers
Pink Sheet
REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'
Pink Sheet
Initiator Or Facilitator? Gottlieb Reflects On First Year As Head Of US FDA
Pink Sheet
Gottlieb: Real Risk Of Congressional Action If Anti-Competitive Actions Continue
Pink Sheet
US FDA Biosimilar Guidance Update Will Relax Interchangeability Standards
Pink Sheet
CDER Director Woodcock Plans Changes To Drug Reviews During OND Transition

Topics

Advertisement
Tags:
Risk Management Generic Drugs Pricing Debate
UsernamePublicRestriction

Register

PS123114

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

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