Research Practitioner articles from July 2007

Research Practitioner archives from July 2007

New regulations for dietary supplements.(In the News)
July 1, 2007... On June 22, FDA issued a new set of regulations governing the manufacturing of dietary supplements, achieving a goal first set out in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The aim of the final rule, titled Current...

The Supreme Court and medical devices.(In the News)
July 1, 2007... If a patient is injured by an FDA-approved medical device, can he sue the manufacturer under state law? On June 25, the U.S. Supreme Court announced that it would hear an appeal in a case that raises exactly this question. In 1996, after...

Ball of confusion: how stem cells have stymied review boards.
July 1, 2007... Since the first human embryonic stem cells were isolated in 1998, most of the research being conducted in the United States has been privately funded because of restrictions on federal funding of any research involving the human embryo....

Supervisory responsibilities of investigators.
July 1, 2007... The U.S. Food and Drug Administration (FDA) announced the release of on important draft guidance document in the May 10, 2007, Federal Register. This document, titled Protecting the Rights, Safety, and Welfare of Study Subjects--Supervisory...

How to critically review and appraise published clinical literature.
July 1, 2007... Regulatory affairs professionals and clinical scientists often are required to critically review and appraise published clinical literature for many reasons: * To substantiate statements in regulatory documents, such as investigators'...

NIH proposed rule to permit multiple principal investigators.
July 1, 2007... In the June 25, 2007, Federal Register, the National Institutes of Health (NIH) published a proposed rule to amend existing regulations governing grants for research projects by revising the definition of Principal Investigator to mean one or...

FDA releases final guidance on computerized systems used in clinical trials.(Regulatory Update)
July 1, 2007... In the May 10, 2007, Federal Register, FDA announced the availability of a final guidance for industry titled Computerized Systems Used in Clinical Investigations, dated May 2007. This document provides sponsors, contract research...

FDA releases final guidance on pandemic influenza vaccine.(Regulatory Update)
July 1, 2007... In the June 1, 2007, Federal Register, FDA announced the availability of a final guidance document titled Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines, dated May 2007. This guidance...

FDA releases final guidance on seasonal inactivated influenza vaccine.(Regulatory Update)
July 1, 2007... In the June 1, 2007, Federal Register, FDA announced the availability of a document titled Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines, dated May 2007. The guidance document...

FDA releases final guidance on clinical trial endpoints for cancer drugs/biologics.(Regulatory Update)
July 1, 2007... In the May 16, 2007, Federal Register, FDA announced the availability of a guidance for industry titled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. This final guidance document provides recommendations to...

FDA solicits members for new risk communication advisory committee.
July 1, 2007... In the June 5, 2007, Federal Register, FDA announced the creation of a new Advisory Committee and solicited members for that committee. Under the Federal Advisory Committee Act, the FDA Commissioner announced the establishment of the Risk...

FDA draft guidance on developing drugs and biologics for malaria.(Regulatory Update)
July 1, 2007... In the June 7, 2007, Federal Register, FDA announced the availability of a draft guidance document for industry titled Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis. This draft document addresses...

FDA public workshop on anthrax vaccines.(Regulatory Update)
July 1, 2007... In the June 18, 2007, Federal Register, FDA announced a public workshop titled Anthrax Vaccines--Bridging Correlates of Protection in Animals to Immunogenicity in Humans. The purpose of the workshop is to discuss possible strategies for...

Sponsor-investigator FDA warning letter.(Regulatory Update)
July 1, 2007... An April 3, 2007, FDA Warning Letter was issued to Thomas P. Davis, from the Cardiology Division at St. John Hospital and Medical Center in Detroit, MI. The inspection on which this letter was based occurred between November 20 and December...