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FDA seeks $5.1 billion total for FY 2017, including funds to implement food safety law, improve medical product safety and quality

The U.S. Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President?s fiscal year (FY) 2017... read more

Califf, FDA top officials call for sweeping review of agency opioids policies

In response to the opioid abuse epidemic, today Dr. Robert Califf, the FDA?s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching... read more

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in... read more

FDA approves first drug to show survival benefit in liposarcoma

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot... read more

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure

The FDA is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary... read more

Summary Information for: Animas Vibe System

Labeling, Approval Order, and Summary of Safety and Effectiveness for Animas Vibe System (P130007S004).

Federal Register: Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices''. The guidance identifies the types of UHMWPE... read more

Check the CDRH Customer Service Score

This page provides real time results for CDRH's customer satisfaction survey.

What's New: Vaccines, Blood & Biologics RSS Feed

Urgent Medical Device Removal: HIV-1 MONITOR Test, v1.5

COBAS AMPLICOR HIV MONITOR Test, v1.5

Jobs at the Center for Biologics Evaluation and Research (CBER)

Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010

Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating

Biologics Guidances

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