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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.

Human Drugs

Lawmakers Urge Justice Dept. to Go After Generic Firms

Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) urge the Justice Department to investigate 20 generic drug manufacturers for allegedly e...

Medical Devices

Bio-Techne Prostate Test Gets 'Breakthrough'

FDA grants Bio-Techne a breakthrough device designation for its ExoDx Prostate IntelliScore test, which the company says is the first exosome-based li...

Federal Register

Industry Reps Sought for CBER Advisory Committee

Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry representative to se...