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Some Post-Approval Studies Need a Long Time: Opinion Post

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Forbes contributor John LaMattina defends the long time needed to complete some drug post-approval studies.

Doctor Sues FDA Over Internet Abortion Drugs

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A Dutch physician sues FDA in Idaho federal court after the agency seized several international packages containing abortion drugs...

Info Collection for Symbols in Device Labeling

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Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices; Use of Symbols in Labeling G...

CGMP Issues in Enprani Inspection

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FDA warns South Koreas Enprani Co. about CGMP and other violations in its manufacturing of finished pharmaceuticals.

CluePoints, FDA Clinical Trial Site Selection Model

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CluePoints and FDA extend their cooperative research and development agreement that is exploring a data-driven approach to selecti...

25 No-Longer-Marketed NDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 25 NDAs from multiple applicants after they notified the agency that the drug p...

Guide on De Novo Device Acceptance Review

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Federal Register notice: FDA makes available a final guidance entitled Acceptance Review for De Novo Classification Requests.

FDA Adopts Unified Units of Measure Codes

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Federal Register notice: FDA announces its adoption of the most current set of the Unified Code for Units of Measure codes.

Act on Vaping or Resign, Durbin Tells Sharpless

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Senator Richard Durbin (D-IL) urges FDA acting commissioner Ned Sharpless to take immediate action to curb the e-cigarette and vap...

FDA Rolling Out IT Modernization Plan Shortly

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FDA acting commissioner Ned Sharpless says the agency is just weeks away from announcing a new plan to modernize its technology in...