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FDA Approves Lilly Lung Cancer Drug

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FDA approves an Eli Lilly NDA for Portrazza (necitumumab) and its use in combination with two forms of chemotherapy to treat patie...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites A-1 Engineering, Advanced Physician Solutions, Inc., d/b/a Advanced Compounding ...

FDA OKs AquaBounty NADA for Salmon

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Federal Register Final rule: FDA approves an AquaBounty Technologies NADA for use of a rDNA gene construct in genetically engineer...

Guidance on Sunscreen Data to Support GRASE

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Federal Register Notice: FDA releases a guidance: Nonprescription Sunscreen Drug Products Content and Format of Data Submissions ...

Guidance on Sunscreen Safety/Effectiveness Data

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Federal Register Notice: FDA releases a draft guidance: Over-the-Counter Sunscreens: Safety and Effectiveness Data.

Prostate Documentation System into Class 2

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Federal Register Final order: FDA classifies the prostate lesion documentation system into Class 2.

Amag Pharma Responds to Makena Complete Response

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Amag Pharmaceuticals responds to an FDA complete response letter on its submission seeking approval for a new single-dose, preserv...

Angiodroid Withdraws 510(k) for Angiography CO2 Injector

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Angiodroid America withdraws a 510(k) submission for the Angiodroid CO2 Injector for Angiography because CO2 gas itself has not be...

FDA Approves Boehringers Pradaxa for Hip Surgery

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FDA approves a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Pradaxa (dabigatran etexilate mesylate) for preventing de...

Panel to Discuss PMA for Spinal Stabilization System

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Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will meet 2/19 to discuss a PMA for the DIAM Spinal Stab...