New FDA Guidance Explains Electronic Record Requirements for Medical Device Clinical Trials
July 25, 2017
By admin

US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. The new guidance applies to clinical trial sponsors and investigators as well as Institutional Review Boards (IRB) and clinical research organizations (CRO) that must comply with 21 CFR Part 11 regulations pertaining to electronic records and signatures. The FDA requires that electronic records and signatures are reliable and trustworthy, and that validations of electronic systems are carried out using risk-based approaches. Types of electronic records covered by the

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Consent Decrees
July 6, 2017
By Devin McElroy

The FDA, this morning, issued a press release for a consent decree issued against Medistat by a U.S. District Judge (see attached article for details). What is a consent decree and what actions cause one to be issued? A consent decree is requested by the FDA and issued by a Federal Judge against a company that has had numerous, unresolved violations against U.S. regulations for medical device or pharmaceutical manufacturing. Typically this process starts years before with a series of FDA Form 483 (Notice of Inspection) findings issued against a

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Navigating the Quality Assurance and Regulatory Landscape in Compounding Pharmacy
May 10, 2017
By Washington M. Osiro

Contributors Author: Washington Osiro, M.B.A (cand.) Reviewers: Devin McElroy, Ph.D. (cand.), CSSGB, CQA Sormeh Mahjouri, MPH Introduction This article provides an overview of the compounding pharmacy industry given reports of adverse events[1], some resulting in patient deaths, that has befallen it. The summary is designed to provide compounding pharmacy management a brief history and state-of-the-industry overview. Between understanding the industry’s history and its current state, management will be better-positioned to formulate a strategy on how to navigate the quality assurance and regulatory landscape in the process assure patient safety by

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