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


Imported bulk drugs

Executive Summary

FDA Commissioner Henney will testify at June 8 House Commerce/Oversight Subcommittee hearing on importation of "counterfeit or substandard" bulk drugs. Commerce Committee Chairman Bliley (R-Va.) recently sent a letter to Henney describing the findings of the committee's investigation into bulk gentamicin imported from China (1"The Pink Sheet" May 15, p. 14)

You may also be interested in...

Bliley Requests FDA Plan To Link Bulk Drug Imports With GMP Compliance

Rep. Bliley (R-Va.) is asking FDA to formulate a plan to provide import inspectors with access to good manufacturing practices compliance information to determine whether bulk drugs should be detained.

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

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials




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