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FDA Proposes to Withdraw Kremers Generic Concerta

[ Price : $8.95]

Federal Register Notice: FDA proposes to withdraw ANDA approval for methylphenidate hydrochloride extended-release tablets, and is...

FDA Proposes Withdrawal of Mallinckrodts Generic Concerta

[ Price : $8.95]

Federal Register Notice: FDA proposes to withdraw ANDA approval for methylphenidate hydrochloride extended-release tablets, and is...

Proposal to Add 3 Drugs to Withdrawn List for Compounding Ban

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Federal Register Notice: FDA proposes to amend its regulations to add three drugs to the list of drug products that have been with...

Class 2 Designation for Upper Extremity Prosthesis

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Federal Register Final Order: FDA classifies as Class 2 (special controls) the upper extremity prosthesis including a simultaneous...

Virtus Pharma Sues FDA Over Unapproved Drugs Guidance

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Virtus Pharmaceuticals files suit against FDA in middle Florida federal court seeking an order barring enforcement action against ...

Sarepta Duchenne Drug Approval Gains Voucher

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Federal Register Notice: FDA issues a priority review voucher to Sarepta Therapeutics after determining its NDA for Duchenne muscu...

Proposed Rule on Home-use Device e-Submissions

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Federal Register proposed rule: FDA proposes to implement provisions requiring electronic submission of the device label and packa...

FDA Classifies Apical Closure Devices as Class 2

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Federal Register Final Order: FDA classifies the apical closure device into Class 2 (special controls).

Cancer Moonshot Report Highlights Strategic Goals

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President Obamas Cancer Moonshot initiative releases a task force report on implementation plans.

FDA Clears Teleflex Arrow Midline Antimicrobial Catheter

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FDA clears a Teleflex 510(k) to market its Arrow Midline with Chlorag+ard Technology, an anti-thrombogenic and antimicrobial perip...