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Apple adds medication tracking to iPhone and Apple Watch

pharmaphorum

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog: Biosimilars

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. Loose Ends IDEs.

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FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2016; 46: 479–93. Clin Microbiol Infect.

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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

ID Stewardship

It’s from 2016 about the future of antibiotics and resistance, but it remains highly relevant today and people consistently give positive feedback about it. Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant.

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Finalizing the Quality Management System Regulation – A High Priority for End of 2023

FDA Law Blog: Biosimilars

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). In fact, the priority designation for the final rule is labeled as “economically significant.” According to the Unified Agenda, the proposed rule is in the final rule stage.