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Comments Sought on IND Reporting Requirements Extension

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Federal Register Notice: FDA seeks comments on a submission to OMB seeking to extend an information collection related to Format a...

Draft Guide on Women Sexual Dysfunction Drugs

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Federal Register Notice: FDA makes available a draft guidance on Low Sexual Interest, Desire, and/or Arousal in Women: Developing ...

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...

Eteplirsen Worrisome Model for Drug Approval: Authors

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Two Harvard Medical School professors question the process FDA used to approve a new Duchenne muscular dystrophy drug.