FDA Related News

Human Drugs

OncBioMune Submits ProscaVax Protocol

OncBioMune submits a ProscaVax prostate cancer vaccine Phase 2 trial protocol to FDA.

HHS Describes 2 Recent Settlements

An HHS Inspect General semi-annual report describes settlements with a drug company and a durable medical equipment manufacturer.

Medical Devices

CDRH ODE Director Sheets Resigns

After less than a year on the job, CDRH Office of Device Evaluation director John Sheets leaves the agency to pursue other opportunities.

Human Drugs

FDA Publishes Qualgen 483

FDA publishes an FDA-483 with five observations from its inspection at Qualgen, an outsourcing facility.

Human Drugs

NIH Pushes Opioid Abuse Research

NIH director Francis Collins says the agency will accelerate opioid research in three key areas.

Human Drugs

Eight Observations in Fusion IV FDA-483

FDA publishes an FDA-483 with eight observations from an inspection at Fusion IV Pharmaceuticals.

Biologics

About 2,500 HCT/P Inspections in 4 Years

FDA releases information on four years of human cells, tissues, and cellular and tissue-based products inspections and follow-up actions.

Human Drugs

FDA Approves Nexus Pharmaceuticals Generic Nitropress

FDA approves a Nexus Pharmaceuticals ANDA for generic sodium nitroprusside injection, indicated for the immediate reduction of blood pressure of adult...

Human Drugs

FDA Approves Multiple First Generics of Lillys Strattera

FDA approves multiple drug manufacturers ANDAs for the first generic versions of Eli Lillys Strattera (atomoxetine) for treating attention-deficit/hyp...

Human Drugs

Better Communications Needed for Faster ANDA Approvals

Lachman Consultants says FDA and industry need to work together on improving communications to achieve more first-cycle ANDA approvals.