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FDA General

OMB Guidance on Hiring Freeze Gives FDA Wiggle Room

The U.S. Office of Management and Budget releases guidance on the Trump Administrations hiring freeze that appears to give latitude to agencies, like ...

Medical Devices

FDA Grants Abbott Emergency Use OK for Zika Test

FDA grants Abbott an emergency use authorization for its Abbott RealTime ZIKA test, a molecular test for detecting Zika virus in whole blood.

Marketing

Ads Make Patients More Inquisitive: Doc Survey

An InCrowd microsurvey of doctors finds that two-thirds want drug DTC ads improved but not banned.

Marketing

Flat Ad Enforcement in 2016

Eye on FDA says OPDP enforcement letter remained relatively flat in 2016 and perhaps revealed an emphasis on citing promotion of unapproved drugs.

Human Drugs

Natco Pharma Inspection Report

FDA releases its FDA-483 on an inspection at Indias Natco Pharma.

Human Drugs

Some Thawing in FDA Drug Communication Approach: Attorneys

Akin Gump attorneys analyze four communications documents issued by FDA in the final days of the Obama administration.

Human Drugs

Tiny WV Town Sues Drug Firms for Opioid Devastation

West Virginia Sen. Joe Manchin blames FDA and DEA, in part, for devastation in the tiny town of Kermit as it sues five drug wholesalers and a medical ...

Human Drugs

Raise the Bar on First-in-Human Trials: Ethicists

Two Canadian medical ethicists say that efficacy of investigational drugs should be considered before the drugs start first-in-human trials.

Human Drugs

FDA Priority Review for Hepatitus C Therapy

FDA accepts for priority review an AbbVie NDA for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir for treating all major genoty...

Human Drugs

Bad Idea to Eliminate Phase 2 or Phase 3 Trials: Academics

Two medical academics write in The Scientist that it would be unwise to speed up drug development and approvals by reducing or eliminating Phase 2 or ...