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What They Said – Reviewing the First 6-Months of FDA Communications

Eye on FDA

Every six months, we do a look-back to see what has changed in the way that FDA is communicating. In 2018, FDA issued a much larger number of releases – trend that continued through 2022, all years with much larger numbers than were seen in 2017. Overall, there have been shifts in the way the agency is communicating.

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Ex-Theranos exec Sunny Balwani gets 13 years for fraud

pharmaphorum

She has until 3 March next year to submit documentation to the appeals court, ahead of the scheduled start of her prison sentence on 27 April. They also used direct communication, marketing materials, media and financial statements, models and other information to defraud potential investors, according to the complaint.

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Impact of Prior Work Experience on Student Pharmacist Success

Pulses

This shift highlights the significance of effective communication, teamwork, and adaptability. Despite the challenge of quantifying these skills, their influence on a student’s ability to cultivate professional relationships, effectively communicate, and collaborate in a team cannot be overstated. teacher), entertainment (ex.

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Five Lessons Learned About Antimicrobial Stewardship Metrics

ID Stewardship

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

The fourth version was introduced in 2018. Holography can also be integrated with secure web interfaces to help eliminate rogue ordering of products while authorised distributors can pick, pack and ship items in carefully measured quantities to customers, with the product’s movements throughout the supply chain, fully tracked and documented.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog: Biosimilars

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

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NHC Comments on Key Information and Facilitating Understanding in Informed Consent

Putting Patients First Blog

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. Clarity in communication is not just about convenience; it is a fundamental aspect of ethical medical practice and research.