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MRI Interventions ClearPoint Software Upgrade

[ Price : $8.95]

FDA clears an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0.

FDA Transitional Biologics Position Ripe for Litigation: Attorneys

[ Price : $8.95]

Attorney Scott Lassman says protein drug sponsors may sue FDA over a 2016 draft guidance on requiring BLAs for such products as of...

FDA Releases Akorn FDA-483 with 11 Observations

[ Price : $8.95]

FDA releases the latest FDA-483 detailing problems at another Akorn manufacturing facility, this time in Somerset, NJ.

Generic Drug Industrys Trade Agreement Concerns

[ Price : $8.95]

The Association for Accessible Medicines calls for changes to the proposed U.S.-Mexico-Canada Free Trade Agreement to better prote...

Facilitating Surrogate Endpoints in Drug Development

[ Price : $8.95]

FDAer Abena Agyemanm says the agency has published a table of surrogate endpoints that were used or could be used to indicate effi...

Ortho Vitros HIV Test Approved

[ Price : $8.95]

FDA approves Ortho Clinical Diagnostics Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Orthos V...

Guide on Developing Hypertension Combo Drugs

[ Price : $8.95]

FDA releases a guidance on Hypertension: Developing Fixed-Combination Drug Products for Treatment.

Info Collection Revision on Tropical Disease Vouchers

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision for Tropical Disease Priority Review Vouchers.

Clinical Trial Meta-Analysis Guidance Out

[ Price : $8.95]

FDA issues a draft guidance outlining factors it will consider when evaluating the strength of evidence provided by drug safety me...