08/02/2022
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The Medicines and Healthcare products Regulatory Agency (MHRA) announced its plans to strengthen regulations for medical devices within the United Kingdom (UK).
Therapeutic Equivalence Draft Guidance. Comment Now!
07/26/2022
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The US Food and Drug Administration (FDA) released a draft guidance “Evaluation of Therapeutic Equivalence” July 2022 on how it evaluates therapeutic equivalence (TE) and assigns therapeutic equivalence codes. Therapeutic equivalence means that drugs are 1) pharmaceutically equivalent, 2) bioequivalent, and 3) have the same clinical effect and safety profile.
CRO Oversight Essentials Article Published in Clinical Leader
07/19/2022
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Our article “CRO Oversight Essentials” was recently published in Clinical Leader. Following are some key points.
Oversight does not mean micromanagement. A CRO is contracted for its specific capabilities. It is important to allow the CRO to do whatever it does best and not to overcontrol how they implement.
Comment Now! Patient Focused Drug Development COA Draft Guidance
07/12/2022
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The US Food and Drug Administration (FDA) released a draft guidance “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments” June 2022. The focus of the draft guidance is on selecting, modifying, developing, and validating clinical outcome assessments (COA), such as patient reported outcome (PRO), that are meaningful to patients, with an emphasis on methods to ensure high quality measures are utilized.
Randomization and Blinding Issues Investigator Warning Letter
07/05/2022
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A recently posted investigator warning letter cited three separate findings. The first was issues with improperly randomizing participants to treatment arms. Participants received the investigational product (IP) instead of the protocol specified