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Marketing

Drug Companies See Coupons as Financial Risk

MarketWatch says drug companies fear that new co-pay accumulator initiatives will lower their sales as patients look for lower-cost alternatives.

Human Drugs

Court Allows Amended Proscar Complaint

A Massachusetts state court says a plaintiff may amend one element of his complaint against Merck alleging intentional failure to update the Proscar l...

Medical Devices

FDA Clears Restoration Robotics Hair Restoration Device

FDA clears a Restoration Robotics 510(k) to expand the Artas hair restoration technology to include robotic implantation.

Human Drugs

Pfizer/Astellas sNDA Accepted for Xtandi

FDA accepts for priority review a Pfizer and Astellas Pharma supplemental NDA for Xtandi (enzalutamide) for an expanded indication to include men with...

Medical Devices

Exactech 510(k) Cleared for Novation XLE Hip Liners

Exactech gains 510(k) clearance to market the Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery.

Human Drugs

Trump Threatens to Sue Pharma Companies Over Opioid Crisis

President Trump warns pharmaceutical companies marketing opioid and other addictive pain killers that the Department of Justice is looking very seriou...

Medical Devices

Quality System Violations at Vilex

FDA warns Vilex in Tennessee about Quality System violations in its work involving Class 1 and 2 orthopedic implants and tools.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Diamond Wipes International, Labocont Industrial, Malladi Drugs & Pharmaceuticals and V...

Medical Devices

Life Spine Lumbar Fusion Spacer System Cleared

FDA clears a Life Spine 510(k) for the Plateau-LO Insert and Rotate Spacer System and its use in micro-invasive lumbar interbody fusion procedures.

Federal Register

Comments Extended on Homeopathic Drug Guidance

Federal Register notice: FDA extends by 60 days the comment period on a 12/20/2017 Federal Register notice entitled Drug Products Labeled as Homeopath...