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

OMB’s GMP edits

This article was originally published in The Tan Sheet

Executive Summary

Dietary supplement GMP draft proposal's description of "uncertainties in the analysis" of the cost and benefits of the rule beefed up by the agency following pre-publication review by the OMB Office of Information & Regulatory Affairs. More than two pages outlining health benefit assumptions added to final Federal Register version. Industry groups have criticized the analysis as overestimating the benefits and underestimating the cost of the proposed GMPs (1"The Tan Sheet" Sept. 15, 2003, p. 13). FDA recently released the marked up version of the draft proposal in observation of Executive Order 12866 requirements for disclosure regarding "significant regulatory actions"...
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS096272

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