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QS Problems Found at Childrens Medical Ventures

[ Price : $8.95]

FDAs Philadelphia District Office warns Childrens Medical Ventures/Philips Healthcare about Quality System violations in its manuf...

Kentz Product Inspection Finds QS Violations

[ Price : $8.95]

FDA warns Japans Suzuken Company about Quality System violations in its manufacturing of Holter monitor medical devices and electr...

CDER Draft Guidance on ANDA Controlled Correspondence

[ Price : $8.95]

CDER posts a draft guidance on Controlled Correspondence Related to Generic Drug Development that provides information on the proc...

QS, MDR Problems Found at Pharma Tech Solutions

[ Price : $8.95]

FDAs Los Angeles District Office warns Pharma Tech Solutions about Quality System and Medical Device Reporting regulation violatio...

FDA Grants Insys Therapeutics Orphan Drug Status

[ Price : $8.95]

FDA grants Insys Therapeutics an orphan drug designation to its pharmaceutical cannabidiol for treating glioblastoma multiforme.

St. Jude Resolves FDA Warning Letter

[ Price : $8.95]

FDA tells St. Jude Medical that issues cited in a 2009 Warning Letter about an inspection at the firms Plano, TX facility have bee...

10% Increase on Tropical Disease Priority Review Vouchers

[ Price : $8.95]

FDA raises by 10% the annual fee for using a tropical disease priority review voucher for fiscal year 2015.

NAFTA Sides with FDA in Apotex Import Alert Flap

[ Price : $8.95]

A North America Free Trade Agreement tribunal sides with FDA by rejecting the companys claims that the agency violated NAFTA by pr...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Ad-Med Biotechnology, LLC A.M.S. Bioteck, Big Easy Confections, Calaire Chimie, ...

CDER Online Establishment Listing/Registration Course

[ Price : $8.95]

CDER posts an online training course entitled Human Drug Establishment Registration and Drug Listing Compliance.