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

Intouch Solutions

While RSAs have been around since 2019, pharma and other regulated industries have been slow to adopt them because of the inherent lack of control of the ad elements that is given to advertisers. Concerns for Pharma Marketers Special care must be taken to accommodate the stringent regulations for pharmaceutical ads. Source: Google.

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

FDA Law Blog

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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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.