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



Executive Summary

NEW IND COVER FORM, DESIGNED TO ENCOURAGE BATCH SUBMISSIONS, is now available at FDA. The agency announced the availability of the new cover form (FDA 1571) and a revised "statement of investigator" form (FDA 1572) in the Sept. 17 Federal Register. In addition to the batching of submissions, the new IND form calls for all submissions to be numbered sequentially for more easy tracking by the firm and FDA. FDA officials highlighted the new form at a Sept. 9 Drug Information Association (DIA) meeting in Rockville, Md. Lee Ripper, special assistant to the director, Office of Biologics Research & Review, noted at the meeting that both the batching and the sequential numbering of submissions provided for in the new form represent a change from instructions in the IND Rewrite regulations. The IND Rewrite provided for separate serial numbering of protocol amendments and information amendments. "Upon further consideration after publishing of the IND Rewrite," Ripper explained, FDA "concluded that the separate sets of serial numbers, which altogether would apply to some but not all submissions, would be confusing for both you and us to implement and maintain." In keeping with the instructions on the new forms, Ripper explained that FDA will publish a technical amendment to the IND regs providing for a single serial numbering system to be applied to all IND submissions. Under the new system, Ripper stated, "safety reports, annual reports and all kinds of correspondence should be [sequentially] numbered as well as protocol amendments and information amendments." The purpose of the numbering system, the FDAer said, "is to allow you and us some assurance that all submissions are received by FDA and properly processed." Ripper noted that the numbering system is prospective: "No attempt should be made to retrospectively number submissions already received by FDA." The FDA rep explained that, although the Rewrite "implies that each submission may contain only one type of document, for example, either a protocol or an information amendment," the new cover form is designed to encourage the batching of different types of submissions. "We strongly encourage you to batch all types of submissions whenever possible," Ripper told DIA. The new IND cover form provides boxes to be checked to identify the types of submissions that it accompanies. A revised "statement of investigator" form is also now available from FDA. In addition to information on the training of the investigator and the names of the sub-investigators, the revised form asks for the name and address of clinical lab facilities to be used and of the responsible institutional review board, and the protocol name and number of the study the investigator will be conducting.

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




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