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FDA Clears EDDA Tech 3D Surgical System

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FDA clears an EDDA Technology 510(k) for the IQQA Guide system, a device that supports intra-operative precision 3D navigation for...

Tylenol with Codeine Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Tylenol with Codeine in different strengths was not withdrawn from sale for reasons o...

Meeting on Patient-Focused Psoriasis Drug Development

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Federal Register Notice: FDA plans a public meeting 3/17/16 on Patient-Focused Drug Development for Psoriasis.

Another Senator Opposes Califfs Nomination

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U.S. senator Lisa Murkowski (R-AK) says she will oppose Robert Califfs nomination to become the next FDA commissioner due to the a...

FDA Releases Dr. Reddys Warning Letter

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FDA releases its 11/5 Warning Letter to Dr. Reddys Laboratories detailing findings from inspections at three of the companys facil...

FDA Guidance on Medical Gas Certification Under FDASIA

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FDA posts a draft guidance on Certification Process for Designated Medical Gases that explains how the agency administers the cert...

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...

Allow Importation of Some Canadian Drugs: Senators

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Sens. Grassley and McCain say that HHS should certify importation of prescription drugs from Canada when certain conditions are me...