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Innovative Trial Design Work Highlighted in CDER Report

[ Price : $8.95]

A new CDER Office of New Drugs annual report highlights some of its work with sponsors to advance innovative clinical trial design...

Nasal Spray Film Cleared for Allergic Rhinitis

[ Price : $8.95]

FDA clears an Altamira Therapeutics 510(k) to market its nasal spray Bentrio for treating allergic rhinitis.

Acutus Expands Left-Heart Access Devices

[ Price : $8.95]

FDA clears an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use ...

Guide on Oligonucleotide Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of...

AbbVie sNDA for Qulipta to Prevent Chronic Migraine

[ Price : $8.95]

AbbVie submits an sNDA for Qulipta as a preventive treatment for chronic migraine.

Amryt Seeking Dispute Resolution on Filsuvez NDA

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Amryt seeks FDA formal dispute resolution over a complete response letter it received in February for its NDA for Filsuvez (oleoge...

Ex-Pharmatech CEO Pleads Guilty to Defrauding FDA

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Former Pharmatech CEO Raidel Figueroa pleads guilty to conspiring to defraud FDA, among other charges, in a case involving contami...

Alternate e-Format Guide for Drugs/Biologics

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FDA makes available a guidance entitled Providing Regulatory Submissions in Alternate Electronic Format.

Blood-Brain Barrier Disruptor Device Gets Breakthrough

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FDA grants Carthera a breakthrough device designation for its SonoCloud-9 system, a device that uses low intensity pulsed ultrasou...

Info Collection on Human Subject Protection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Protection of Human Subjects; Informed...