The FDA’s new transparency policy (Part 3)

As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...

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FDA’s new CSA guidance: transforming software validation for production and quality systems

FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.

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The New Precise Magazine is Available Now

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Astra Zeneca’s asthma drug nears approval for sinus inflammation

Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.

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Heart Monitoring in Breast Cancer – Essential or Excessive?

Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...

New version of ISO 10993-1: the core standard for the biological evaluation of medical devices

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...

Del 3 av Advance serien: Design

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The FDA’s new transparency policy (Part 2)

In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...

Eli Lilly requests re-examination of Alzheimer's drug recommendation

Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.