Latest FDA News and Information

FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma

The U.S. Food and Drug Administration today granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers... read more

FDA awards 21 grants to stimulate product development for rare diseases

The U.S. Food and Drug Administration today announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the... read more

FDA warns against the use of homeopathic teething tablets and gels

The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop... read more

FDA Statement from Todd Simpson, FDA Chief Information Officer (CIO) on GAO Report Regarding FDA?s IT Security Program

Information security and the protection of industry and public health information are among the FDA?s highest priorities and we do not take lightly the recommendations provided by the GAO... read more

Food and Drug Adminstration (FDA): CDRHNew

FDA Voice blog: FDA is working with hospitals to modernize data collection about medical devices

As the nation’s hubs for real-time health care data, hospitals are uniquely positioned to help identify new safety problems with devices as well as changes in the frequency of... read more

Letter to Viracor-IBT Laboratories, Inc. regarding Zika Virus IgG, and Zika Virus IgG and IgM Panel

Letter to Viracor-IBT Laboratories, Inc. regarding Zika Virus IgG, and Zika Virus IgG and IgM Panel

Federal Register: Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System

The FDA is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in this order and... read more

Federal Register: Program for Parallel Review of Medical Devices

The FDA and the Centers for Medicare & Medicaid Services are informing the public that the Parallel Review of medical devices pilot program will be fully implemented and extended indefinitely.... read more

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

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

EVARREST (Fibrin Sealant Patch)

Complete List of Substantially Equivalent 510(k) Device Applications

Information updated through September 30, 2016

November 29, 2012: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement: Final Roster

Final Roster


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