FDA Related News

FDA Alliance Lobbies for $78 Million Budget Boost for FDA

Alliance for a Stronger FDA completes its annual agency budget analysis and has determined FDA needs $2.8 Billion or 3% ($78 million) more in FY 2018 ...

Federal Register

FDA/Xavier Host Conference on Global Supply Chain

Federal Register Notice: FDAs Cincinnati District co-sponsors with Xavier University a public conference 3/15-17 entitled FDA/Xavier University Pharma...

Animal Drugs

First Heartworm Generic Drug for Dogs Approved

FDA approves Anzac Animal Healths Diroban (melarsomine dihydrochloride), the first generic drug to treat heartworm disease in dogs.

Medical Devices

FDA Clears Medtronic Signia Stapling System

FDA clears a Medtronic 510(k) of its Signia Stapling System that enables one-handed staple firing.

Marketing

Fenwal InterSol Slides Mislead on Safety, Efficacy: FDA

CBER warns Fenwal about an InterSol slide show that misleads viewers about the drugs safety and effectiveness.

Human Drugs

CDER Benefit/Risk Structured Framework Explained

Three CDER staffers explain the Centers new structured framework for drug benefit/risk evaluation.

Human Drugs

Fast Track Status for Axsome Depression Drug Combo

FDA grants Axsome Therapeutics fast track status for AXS-05 (bupropion and dextromethorphan) for treating treatment-resistant depression.

Biologics

FDA Accepts Biosimilar Submission for Copy of Neulasta

FDA accepts a Mylan and Biocon BLA for MYL-1401H, a proposed biosimilar version of Amgens Neulasta (pegfilgrastim), indicated for reducing the duratio...

Human Drugs

CDER Considering 101 New and Revised Guidances

CDER publishes a 2017 guidance agenda showing plans to publish 101 new and revised guidances in 16 categories.

Human Drugs

New Data Auditing Process Needed: Consultant

Unger Consulting recommends a focused auditing approach to drug quality systems to first ensure that data generated by the systems are trustworthy.