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Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management

ProRelix Research

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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FD-AID, LLC Announces Expansion of Services to India’s Pharmaceutical Sector

Pharma Mirror

Spearheaded by a former US FDA Investigator and seasoned pharmaceutical executive, FD-AID is uniquely positioned to bring a wealth of expertise and insight to India’s rapidly growing pharmaceutical industry.

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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials.

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FDA Flips It and Reverses It: FDA Withdraws HHS Withdrawal of UDI Guidance

FDA Law Blog

Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved DrugsCompliance Policy Guide Sec.