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

FDA ANIMAL TESTING REQUIREMENTS TO BE HARMONIZED WITH EC, JAPAN, AGENCY SAYS

Executive Summary

FDA will accept animal test data from the European Community and Japan under a proposed guidance to be published in an upcoming Federal Register. "This will greatly reduce overlapping tests and decrease the cost of product development," HHS Secretary Sullivan stated at an April 9 press conference on implementation of drug approval process reforms proposed by Vice President Quayle's Council on Competitiveness. Harmonization of drug approval requirements was one of 11 reforms recommended the Competitiveness Council in November. A fact sheet issued by the White House says that "under the FDA's new guidance, animal test data developed for foreign countries under consensus standards adopted by FDA and other countries can be accepted for review in the United States, thus eliminating the burden of multiple studies." The harmonization initiative "will reduce the time currently required for long-term testing by six months or more," a same-day FDA release notes. In November, following the first International Conference on Harmonization, the EC announced that the U.S., Japan and the EC had agreed to shorten the repeated-dose safety studies from 12 to six months and standards for determining delayed toxicity and appropriate dosing levels ("The Pink Sheet" Nov. 18, 1991, p. 7). The regulatory bodies also agreed to delete the LD[50] test from animal testing requirements. The fact sheet notes that the guidance is "one of a series of consensus agreements with the European Community and Japan that will harmonize scientific requirements and technical standards and that will reduce the time and resources currently required for drug testing." The guidance "is a first step toward international harmonization and reciprocity of drug approval requirements," the document adds.

You may also be interested in...



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

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

OM006051

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

Cancel