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Cranial Motion Measurement Device Into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies as a Class 2 (special controls) medical device the cranial motion measurement device.

Workshop on Real World Evidence

[ Price : $8.95]

Federal Register notice: FDA announces a 9/13 public workshop on Developing a Framework for Regulatory Use of Real-World Evidence....

Workshop on Developing Cardiac Troponin Assays

[ Price : $8.95]

Federal Register notice: FDA announces an 11/28 public workshop entitled Cardiac Troponin Assays to discuss developing the innovat...

Janssen Arthritis BLA has Safety Concern: FDA Reviewers

[ Price : $8.95]

FDA safety reviewers raise some concern with a Janssen Biotech BLA for Plivensia (sirukumab) injection going before the agencys Ar...

FDA Panel Backs Dynavax Hepatitis B Vaccine

[ Price : $8.95]

FDAs Vaccines and Related Biological Products Advisory Committee votes 12 to 1 to recommend approval of a Dynavax Technologies BLA...

National Emergency Declaration Needed for Opioid Crisis: Report

[ Price : $8.95]

A White House-commissioned report urges President Trump to declare a national emergency in order to deal with the ongoing opioid c...

ICU Medical Recalls Sodium Chloride Lot

[ Price : $8.95]

ICU Medical recalls one lot of 0.9% sodium chloride injection, USP 1,000 mL due to a confirmed customer complaint of particulate m...

Apace Packaging Recalls 2 Drug Products Over Mislabeling

[ Price : $8.95]

Apace Packaging recalls one lot of cyclobenzaprine HCl tablets, USP 5 mg 50ct unit dose, and one lot of amantadine HCl capsules, U...

FDA Approves Bracco Swallowing Diagnostic

[ Price : $8.95]

FDA approves a Bracco Diagnostics PMA for Aribar Nectar (barium sulfate) oral suspension for use in modified barium swallow examin...

Adjunctive Cardiovascular Status Indicator Into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies as Class 2 the adjunctive cardiovascular status indicator (special controls).