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Human Drugs

CGMP Violations at Tropical Seas

FDA warns Tropical Seas about CGMP and other violations in its manufacturing of several over-the-counter drugs.

Federal Register

Info Collection Extension for Social/Behavioral Research

Federal Register notice: FDA seeks comments on an information collection extension for Data to Support Social and Behavioral Research as Used by the F...

Federal Register

Info Collection Extension on Device Postmarket Surveillance

Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Postmarket Surveillance of Medical Devices 21 CFR Par...

Medical Devices

Cook Recalls Advance Enforcer Balloon Catheter

Cook Medical recalls its Advance Enforcer 35 Focal-Force PTA Balloon Catheter (6mm x 4cm) after multiple complaints were received for balloons burstin...

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes PRL, Inc. and Tropical Seas.

FDAers Develop Better Poliovirus Assay

FDA scientists say they have developed a new and improved poliovirus assay.

Human Drugs

Drug and Bio Development Times Similar: Analysis

Researchers say there is no significant difference in drug development time between small molecule drugs and biologics.

Medical Devices

Cybersecurity Threat Issued on BD Alaris Gateway

Department of Homeland Securitys National Cybersecurity and Communications Integration Center issues a cybersecurity alert on BDs Alaris Gateway Works...

Human Drugs

1/2 of FDA-Required Post Marketing Studies Get Published

A just-posted article in BMC Medicine finds that about half of studies FDA requires in post-marketing commitments are ever published in peer-reviewed ...

Human Drugs

Expanded Indication for Novo Nordisks Victoza

FDA approves an expanded use for Novo Nordisks Victoza (liraglutide) for improving blood sugar control in pediatric patients with Type 2 diabetes.