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

The FDA Law Blog

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Software in a Medical Device, or SiMD).

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Medical Writing in Enhancing Healthcare Communication

Viseven

It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication. As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

The FDA Law Blog

Below we highlight FDA’s views about best practices for BIMO inspection communications, handling requests for records, and inspection preparation and follow-up as outlined in the draft guidance. FDA investigators routinely share their names, titles, contact information, and, when appropriate, reasons for conducting the inspection.

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ABPI code updated with first social media guidance

pharmaphorum

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. “With its wide reach and international audience, information on medicines can be seen by audiences it wasn’t intended for.”

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EMA guidance aims to prevent medicine shortages

European Pharmaceutical Review

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

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5 Things To Know About Antimicrobial Stewardship Regulatory Standards

IDStewardship

PACCARB provides advice, information, and recommendations to the Health and Human Services Secretary (HHS) regarding programs and policies intended to support and evaluate the implementation of U.S. Today this Taskforce is known as The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, or PACCARB.

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Why intelligent automation is the future for regulation

pharmaphorum

Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data.