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Latest FDA News and Information
FDA Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The... read more
FDA Approves First Generic Ropinirole
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.
Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by... read more
FDA Center for Drug Evaluation and Research - What's New
BPCA/Pediatric Exclusivity Statistics
BPCA/Pediatric Exclusivity Statistics: Written Requests Issued and Pediatric Exclusivity Statistics (updated)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)
Month First-Time Generic Drug Approvals
Office of Generic Drugs: First-Time Generic Drug Approvals
Paragraph IV Patent Certifications
Office of Generic Drugs: Paragraph IV Patent Certifications (updated)
Food and Drug Adminstration (FDA): CDRHNew
Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Slides
On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT?). The IMT?, a visual... read more
PMA Final Decisions for April 2008
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2008.
Summary Information for: Thoratec HeartMate II® Left Ventricular Assist System (LVAS)
PDF format only. Topics: Ventricular Assist Device
Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization
This guidance document describes the general administrative procedures FDA will use to categorize tests under CLIA. This guidance does not specifically address CLIA waiver applications.
What's New at CBER
User Fee
Billable Products Approved Under Section 351 of the PHS Act
Violative Advertising and Promotional Labeling Letter
Thrombin, Topical (Recombinant) (Recothrom) - ZymoGenetics, Inc
Licensed Products and Establishments List
Update
Approved Biological NDA and ANDA Applications
Update
