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Defibtech Recalls Chest Compression Device

[ Price : $8.95]

Defibtech begins a Class 1 recall of its RMU-2000 ARM XR Chest Compression Devices due to a motor problem that may cause them to s...

Wex Pharma Gets Fast Track for Pain Drug

[ Price : $8.95]

FDA gives Wex Pharmaceuticals a fast-track designation for Halneuron (tetrodotoxin for injection), an alternative to narcotics and...

FDA Publishes 68 New, Revised Product-Specific Guides

[ Price : $8.95]

FDA publishes 68 new and revised product-specific guidances to aid in generic drug development.

De Novo Electronic Submission Template

[ Price : $8.95]

FDA publishes a guidance to help submitters of de novo requests use an electronic format template.

Request for Information Guidance

[ Price : $8.95]

FDA publishes a guidance on procedures for submitting section 513(g) requests for information on medical device classification.

Liquidia Sues FDA Over Tyvasos Exclusivity

[ Price : $8.95]

Liquidia Corp. sues FDA over the agencys recent decision to grant United Therapeutics Corp. an additional three-year exclusivity p...

Abbott Labeling Removes Aspirin from Heart Pump

[ Price : $8.95]

FDA approves an Abbott labeling change on its HeartMate 3 heart pump to eliminate aspirin as part of routine patient management.

Expos Hits Ethics Conflicts in Shurens Job and Wifes Industry Roles

[ Price : $8.95]

A New York Times investigative article examines potential conflicts of interest with retiring CDRH director Jeff Shuren and his la...

Medical Device PCCP Guidance

[ Price : $8.95]

FDA publishes a draft guidance with its current thinking on its policy for medical device predetermined change control plans.

PhRMA Seeks Changes in Bio Interchangeability Guidance

[ Price : $8.95]

PhRMA calls on FDA to make changes to a draft guidance on demonstrating biologic interchangeability with a reference product.