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FDA approves expanded indications for Ilaris for three rare diseases

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FDA approves Amjevita, a biosimilar to Humira

The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths

The U.S. Food and Drug Administration today announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients... read more

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device

The FDA is classifying the strabismus detection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be... read more

Meeting Notice: October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee

Meeting Notice: October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee

Federal Register: Technical Electronic Product Radiation Safety Standards Committee; Notice of Meeting

The FDA announces a forthcoming public advisory committee meeting of the Technical Electronic Product Radiation Safety Standards Committee. The general function of the committee is to provide advice and recommendations... read more

Federal Register: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.'' This draft guidance is intended to assist drug... read more

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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

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

FluLaval Quadrivalent

Fluzone Quadrivalent

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