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FDA approves Erelzi, a biosimilar to Enbrel

The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.

FDA advises testing for Zika virus in all donated blood and blood components in the US

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood... read more

FDA Statement on Medical Device User Fee Agreement (MDUFA)

The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user... read more

FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury

The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient?s cognitive function immediately after a suspected brain injury or concussion. The... read more

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

This guidance describes the Agency's intent not to enforce the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels... read more

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150037 added)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150037 added)

Emergency Use Authorization - LightMix® Zika rRT-PCR Test (Roche Molecular Systems, Inc.)

On August 26, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Roche Molecular Systems, Inc.'s LightMix® Zika rRT-PCR Test for the qualitative detection of... read more

Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff

This guidance describes the Agency’s intent regarding enforcement of the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and... read more

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

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of... read more

Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents

This list includes only vaccines for which supporting documents were provided and is arranged alphabetically by the proper name of the product. Information is provided for original product approvals, new... read more

TWINRIX

Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus

Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the... read more

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