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Marketing

Many Drug Field Contacts In Person Again: Veeva Report

The Veeva Field Trends 2022 report says 75% of healthcare providers want contact with drug field staff to be a mix of digital and in-person.

Medical Devices

Transcranial Magnetic Stimulation Cleared for Anxiety

FDA clears a Neuronetics 510(k) for a new indication for its NeuroStar Advanced Therapy for Mental Health device, a transcranial magnetic stimulation ...

Human Drugs

CGMP Deviations at Bioiberica

FDA warns Spains Bioiberica about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

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Human Drugs

False/Misleading Claims for Imprimis Rx Compounded Drugs: FDA

FDA warns Imprimis Rx that professional promotional materials for a compounded ophthalmic drug make false and misleading statements about the drug.

Human Drugs

Clinical Hold Lifted on Viking X-ALD Trial

FDA lifts a clinical hold against Viking Therapeutics VK0214 in patients with X-linked adrenoleukodystrophy.

Human Drugs

Merck Hits Brakes on Lynparza in Colorectal Cancer

Merck halts a Phase 3 LYNK-003 trial investigating Lynparza (olaparib) with or without bevacizumab for treating patients with unresectable or metastat...

Human Drugs

CDERs Cavazzoni Adds Deputy for Substance Abuse

CDER director Patrizia Cavazzoni selects associate director for controlled substances Marta Sokolowska to serve as deputy Center director for substanc...

Caution Advised for Continuing Education Funding: WLF

The Washington Legal Foundation says an OIG advisory opinion puts life sciences companies on notice to be cautious in the way they fund continuing edu...

Human Drugs

Pain Doctor Settles Company Kickback Allegations

California pain doctor Gerald Sacks agrees to pay $271,259.12 to resolve anti-kickback allegations involving drugs manufactured by Purdue Pharma and D...

Medical Devices

Roche Elecsys Amyloid Plasma Panel is Breakthrough Device

FDA grants breakthrough device designation for the Roche Elecsys Amyloid Plasma Panel that detects and measures Alzheimers disease biomarkers in blood...