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FDA Reclassifies Salivary Stimulator

[ Price : $8.95]

Federal Register Final order: FDA reclassifies the salivary stimulator system into Class 2 and renaming it the electrical salivary...

FDA Classifies UV Radiation Chamber into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the ultraviolet radiation chamber disinfection device into Class 2.

FDA Exempts Electric Chair Devices

[ Price : $8.95]

Federal Register Final order: FDA grants a petition seeking exemption from premarket notification requirements for electric positi...

Major Review Concerns on Kyndrisas Safety/Efficacy

[ Price : $8.95]

FDA reviewers express major safety/efficacy concerns that may hamper approval of a Biomarin NDA for Kyndrisa (drisapersen) for tre...

FTC Wants Effexor Court Ruling Reversed

[ Price : $8.95]

The Federal Trade Commission asks an appeals court to reverse a lower court ruling that a Wyeth and Teva Effexor reverse-payment a...

FDA Wants More Makena Info

[ Price : $8.95]

FDA issues a complete response letter seeking more information about Amags application for a single-dose vial of its Makena.

Preemption Defense Alive and Well: Attorneys

[ Price : $8.95]

Two Covington & Burling attorneys say recent court decisions and appeals show that branded drug manufacturers are still making goo...

Shuren Testified Falsely on Morcellators: Activist

[ Price : $8.95]

Anti-morcellator activist Hooman Noorchashm charges that CDRH director Jeffrey Shuren either experienced a critical memory lapse o...

Too Much Being Made of Biosimilar Interchangeability: Woodcock

[ Price : $8.95]

CDER director Janet Woodcock says too much is being made of biosimilar interchangeability and pharmacy substitution as FDA moves t...

Lilly, Merck Extend Combination Drug Pact for Lung Cancer

[ Price : $8.95]

Eli Lilly and Merck extend an existing collaboration to evaluate the combination of Lillys Alimta and Mercks Keytruda in a pivotal...