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STAT+: J&J sues former employee for allegedly taking thousands of documents to a new job at Pfizer

STAT

Johnson & Johnson has accused a long-standing employee of taking thousands of confidential files about commercial strategies as he left for a similar job at Pfizer, according to lawsuit filed in a federal court in New Jersey.

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U.S. Pharmaceutical company improved quality of overall documentation saving time and filing delays

Impact Pharmaceutical Services

Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.

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Whole genome sequencing and analysis of live biotherapeutic products

European Pharmaceutical Review

Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation. Download and read more now… . Among an array of tests suggested for LBP testing, the EMA and FDA have given prime importance to the whole genome sequence characterisation of the strain in the final product dossier.

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Roche debuts smart glucose monitor for hospital use

pharmaphorum

The company has already formed partnerships with other third-party software developers to extend the functions of cobas pulse, which are already bundled with the unit, ready for download, or will be available soon.

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Apple adds medication tracking to iPhone and Apple Watch

pharmaphorum

Users can also use the built-in health records feature on the Health app to download current medications, said Ricky Bloomfield, a former director of mobile strategy at Duke University who joined Apple as clinical and health informatics lead in 2016 in a tweet.

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Is my Software a Medical Device? Use the Digital Health Policy Navigator

The FDA Law Blog

It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop. The following Guidance documents are critical to understanding the FDA’s policy for software products: Changes to Existing Medical Software Policies. The flowchart can be downloaded here.

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How is Your Follow-Through as a Leader?

The Honest Apothecary

Fixing Bad Follow-Through The first step to fixing poor follow-through as a leader is to, beginning today, document everything you are expected to do in writing. Use a Word document or the Outlook task feature. If all you have is a smartphone, download Evernote and start a note entitled “To do.” That is it.