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FDA approves Rapivab to treat flu infection

On December 19, the U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults.

FDA approves Opdivo for advanced melanoma

The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma... read more

FDA approves new antibacterial drug Zerbaxa

The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (... read more

FDA approves Viekira Pak to treat hepatitis C

The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1... read more

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Independent Assessment of the Process for the Review of Device Submissions; Final Implementation Plan

The FDA is announcing the availability on FDA's Web site of the Agency's final implementation plan published as part of Booz Allen Hamilton's independent... read more

Public Workshop - Optimizing FDA?s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop, February 20, 2015

The Food and Drug Administration (FDA) is announcing a public Workshop entitled: ?Optimizing FDA?s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.? The purpose of this workshop is to... read more

Federal Register: Transfer of a Premarket Notification (510(k)) Clearance - Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of ``Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers.'' The purpose of the draft guidance is to provide information on how... read more

Federal Register: Minimizing Risk for Children's Toy Laser Products; Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This guidance is intended to inform manufacturers of laser... read more

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Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff

Fluzone Quadrivalent

Printable Version: Bacterial Detection Testing by Blood and Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry

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