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FDAAA Doesnt Change Preemption: 7th Circuit

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Attorney Stephen McConnell says the 7th Circuit Court of Appeals has ruled that the FDA Amendments Act did not overturn the state ...

FDA, EU Moving Forward on GMP Inspection Mutual Agreement

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FDA and the European Union move forward with a GMP inspection mutual agreement to recognize each others inspectional activities, w...

FDA Approves Medtronic CoreValve Evolut Valve

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FDA approves Medtronics CoreValve Evolut R 34 mm valve, said to be the largest sized transcatheter aortic valve replacement system...

FDA Removing Ozone Exemption for Certain Anesthetics

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Federal Register Proposed Rule: An FDA proposed rule seeks to remove an essential uses designation for certain anesthetic drugs fo...

FDA Removing Ozone Exemption for Aerosol Talc

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Federal Register Proposed Rule: An FDA proposed rule seeks to remove an essential uses designation for certain sterile aerosol tal...

FDA Approves Expanded Indication for Ethicons Evarrest

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FDA approves an Ethicon BLA supplement for an expanded indication for Evarrest Fibrin Sealant Patch, indicated for stopping proble...

FDA Clears Spineology Interbody Fusion Device

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FDA clears a Spineology 510(k) for the Rampart Duo Interbody Fusion System, which the company describes as the first device of its...

Petition to Amend External Analgesic Drug Monograph

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Metabolic Therapy asks FDA to revise its external analgesic drug products monograph to indicate that such products containing mela...

Merck sNDA for 1st Line Keytruda in Lung Cancer Approved

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FDA approves a Merck supplemental NDA for Keytruda (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, ...

FDA Draft Guide on Drugs for Women With Low Sexual Interest

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FDA releases a draft guidance on Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment that is inte...