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

ANDA "FIRST IN-FIRST REVIEWED" POLICY AT FDA will allow for review extensions by the agency staff based on the number and type of amendments following initial submission of an application. According to a March 7 FDA guidance, the priority status of applications will be reviewed based on followup submissions to the agency. The recently-issued guidance supplements the "Division of Generic Drugs Policy and Procedure Guide." Minor amendments to an original ANDA, prior to issuance of an initial action letter, "will add 30 days to the review priority date for the entire application," the guidance states. A minor amendment is defined as one "requiring more than an hour to review." Major amendments, not defined by the guidance, would add 120 days to the review priority date. "Truly minor amendments (that is, not requiring more than one hour to review) do not change the priority for review date," the guidance notes. Amendments in response to action letters also are categorized with specific extensions. Minor amendments, requiring more than one hour, are placed at 30 days from the oldest submission in the reviewers "queue" of applications. "The reviewer must complete work on all submissions from the oldest to 30 days following the oldest before reviewing the 30-day amendment," the guidance states. Accordingly, major amendments submitted in response to an action letter enter the queue at 120 days. The "first in-first reviewed" policy is one of 10 high priorities recommended by Office of Generic Drugs Acting Director Bruce Burlington, MD, in a January memo to Center for Drug Evaluation and Research Director Carl Peck, MD ("The Pink Sheet" Feb. 5, p. 12). In that memo, Burlington estimated that the 10 priorities could be accomplished by July without involvement by other parts of FDA. Several exceptions to the first in-first reviewed procedure are cited by FDA. If two related original application submissions (for example, different strengths or container/closure types) are made at the same time and another related submission is made some time later, the reviewer may take the later submission out of order and review it with the other earlier submissions. Labeling amendments should not delay reviews excessively. The guidance states: "if the review is otherwise complete and satisfactory, such amendments should be considered as having a special high priority." The final exception to the procedure involves minor chemistry deficiencies, where additional stability data, for example, in an amendment would not delay review of the ANDA. FDA generic reviewers must document all exceptions that are made to the policy, the guidance states. In addition, "such exceptions are to be reported by the reviewer to the branch chief during their regularly scheduled monitoring meetings," the guidance notes. "Operationally, the reviewer should note on the pink copy of a not-approvable letter (and make a similar statement in the proposed action letter to the applicant) if the next amendment in response to the letter is a candidate for being taken out of turn," the guidance explains. Submissions that would not qualify for exception to the first in-first reviewed rule include "responses to approvable letters that go beyond the scope of the deficiencies or conditions required for approval." Such responses would be considered major amendments and be assigned a position in the reviewer's queue at 120 days. Amendments to not-approvable letters that fail to address "all the points covered in the letter" are not eligible for exception. FDA said it plans to issue a separate policy guide to cover other submissions such as: "supplements to approved applications; amendments submitted in response to action letters on supplements and amendments submitted at the initiative of the applicant; and annual reports on approved applications."

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

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