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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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What Does Google’s Move to Responsive Search Ads for Paid Search Mean for Pharma?

Intouch Solutions

And educational resources have been created detailing the RSA ad format to share with the audiences who review creative assets for FDA compliance. All newly created ad plans and ad plan updates will heavily feature the RSA ad format.

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

FDA Law Blog

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Summaries of the most striking recently released Warning Letters are included below.

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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 Drugs – Compliance Policy Guide Sec.