March 2007

Mar 02, 2007
By Pharmaceutical Technology Editors
Volume 31, Issue 3


FDA Proposes Additional Information to Current Biologics Reporting Form

Rockville, MD (Jan. 30)—The US Food and Drug Administration's ( http://www.fda. gov/) Center for Biologics Evaluation and Research (CBER) is proposing an addendum to its current biologics reporting form to better classify potential recalls.

FDA must submit such a request to the Office of Management and Budget (Washington, DC, for approval but first open the request for a 30-day public-comment period. Notice of the request was published in the Jan. 30, 2007 issue of the Federal Register (1).

Specifically, CBER is developing an addendum to Form FDA 3486, the form now used to report biological product deviations (BPDs). The Web-based addendum (Form FDA 3486A) would request additional information when a BPD report has been reviewed by FDA and evaluated as a possible recall. The additional information would include information not contained in Form 3486 such as distribution pattern, method of consignee notification, consignee(s) of products for further manufacture, additional product information, and updated product disposition.

This information would be requested by CBER via e-mail to the submitter of the BPD report and would be used by CBER for recall classification.

The new form, Form FDA 3486A, would be used only for biological products regulated by CBER and not biological products regulated by the Center for Drug Evaluation and Research.

CBER estimates that 5% of the total BPD reports submitted to CBER would need additional information submitted in the addendum. It estimates that it would take between 15 and 45 minutes to complete the addendum. Activities such as investigating, changing standard operating procedures or processes, and follow-up are not included in the calculation of time for the report.


1. US Food and Drug Administration, "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products; Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A," Federal Register 72 (19), 4267–4269 (Jan. 30, 2007, Docket No. 2006N-0421),, accessed Jan. 31, 2007.

-Patricia Van Arnum


Pfizer Wins Court Battle Over Manufacturing Process for Norvasc

New York, NY (Jan. 31)—Pfizer, Inc. ( scored a victory over Synthon IP (Gainesville, VA, in a patent infringement lawsuit over the manufacturing process for "Norvasc" (amlodipine). Norvasc is one of Pfizer's top-selling drugs with 2006 sales of $1.3 billion.

According to Pfizer, the federal district court in the Eastern District of Virginia (Alexandria) ruled that Synthon obtained, by inequitable conduct, two US patents that covered a process and an intermediate compound used to make the active ingredient in Pfizer's Norvasc.

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