HBW Insight 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


FDA guidance

This article was originally published in The Tan Sheet

Executive Summary

"Submission of Abbreviated Reports and Synopses in Support of Marketing Applications" guidance, expected to appear in the Sept. 13 Federal Register, describes when studies that are part of an NDA may be submitted to FDA in abbreviated form and describes the format abbreviated submissions should follow. The agency estimates the resulting reduction in burden for industry will be 300 hours. A draft of the guidance appeared in the Sept. 21 Federal Register (1"The Tan Sheet" Sept. 28, 1998, p. 24). Comments may be submitted at any time

You may also be interested in...

Abbreviated Reports May Be Submitted for Studies Not Central To Efficacy

Abbreviated data reports may be submitted for efficacy, safety and pharmacology studies that are not central to efficacy claims for a specific indication, FDA indicates in its guidance for industry on "Submission of Abbreviated Reports and Synopses in Support of Marketing Applications."

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

People In Brief

Perrigo promotes in pricing, planning





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