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


Human subject protections

Executive Summary

FDA Commissioner Henney will be among witnesses testifying before a Government Reform/Criminal Justice, Drug Policy & Human Resources Subcommittee hearing on institutional review boards and federal protections for human research subjects May 3. Subcommittee Chairman Mica (R-Fla.) called the hearing in response to two Inspector General reports on IRBs (1"The Pink Sheet" April 17, p. 28). Also among the witnesses will be NIH Acting Director Ruth Kirschstein, MD, NIH Office of Protection from Research Risks Acting Director Gary Ellis, PhD and Deputy Inspector General George Grob

You may also be interested in...

Gene Therapy Oversight Efforts Should Be Expanded To Other Areas - HHS IG

FDA and NIH should expand improvement efforts in gene therapy trial oversight to other types of clinical trials, the HHS Inspector General suggested in an update on recommendations for protecting human research subjects.

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

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