Auszyme Monoclonal

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Advate

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Thymoglobulin

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Alphanate

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October 29, 2014 Approval Letter

October 29, 2014 Our STN: BL 125549/0                                ACCELERATED APPROVAL Wyeth Pharmaceuticals, Inc. Attention: Carmel M. Devlin 401 N. Middletown Road Pearl River, NY 10965 Dear Ms. Devlin: Effective this date, we have approved your biologics license application (BLA) for Meningococcal…

Draft Guidance for Industry-Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines

Draft Guidance for Industry This guidance document is for comment purposes only. The technical specification associated with this guidance is provided in a separate document and is updated periodically. To ensure that you have the most recent version of the technical specifications document, check the CBER ICSR Specifications Web page at: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm174963.htm Reference Information About…

Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception

PDF Version (63KB) This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance.  Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305),…

Biologics PREA Reviews and Labeling Changes

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