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CluePoints, FDA Clinical Trial Site Selection Model

[ Price : $8.95]

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25 No-Longer-Marketed NDAs Withdrawn

[ Price : $8.95]

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

[ Price : $8.95]

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...

FDA Denies Petition Seeking New Opioid Moratorium

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FDA denies a 3/21 citizen petition from advocacy group Public Citizen that urged the agency to immediately impose a moratorium on ...

2 FDA Guidances on De Novo Device Requests

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FDA issues two guidances related to medical device de novo classification requests one on performance goals and the other on user...

FDA Hits Juul with Warning Letter

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FDA issues a Warning Letter to Juul Labs over marketing unauthorized modified risk tobacco products.

FDA Quality Guide on Real World Data Coming

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FDA says it is developing guidance on data quality issues that pertain to real world data and related study design considerations.