Showing items tagged as FDA

  • Regulatory Manager Tip: Making Your Voice Heard at the FDA

    July 17, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    As a life science manufacturer, how can I minimize risk and hiccups before seeking U.S. Food and Drug Administration approval for my product? Learn how to make your voice heard at the FDA in this month’s Regulatory Manager Tip.

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  • Noteworthy Clinical Trends in Med Device to Watch in 2018

    July 5, 2018 by James Jardine, Staff Writer, MasterControl

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

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  • Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

    June 28, 2018 by David Jensen, Staff Writer, MasterControl

    Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.

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  • How to Make Pre-Sub Program Communication With the FDA More Transparent

    June 26, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    If you're getting close to submitting a medical device for market clearance through the FDA, you may want to read this month's Regulatory Manager Tip. The best type of communication for this process is to create even greater transparency by creating a venue for interaction with FDA staff for a "pre-sub" review of your device submission.

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  • What Biotech Startups Need to Do to Slay the Competition

    June 21, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • What the FDA’s New Ruling Means for Caffeine Supplements

    June 14, 2018 by Sarah Beale, Staff Writer, MasterControl

    Most of us need caffeine to get through the day, whether from coffee, soda or energy drinks. For those seeking alternate sources, nutraceutical companies have been happy to oblige. However, recent headlines about dangerous caffeine supplements and subsequent action by the FDA might be worrisome to consumers and manufacturers.

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  • FDA Backs Cannabis-Based Drug to Treat Kids With Epilepsy

    June 5, 2018 by Marci Crane, Staff Writer, MasterControl

    Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.

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  • The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    May 31, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 2

    May 24, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.

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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 1

    May 22, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.

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  • Top Medical Device Trends in Asia-Pacific and Around the World

    May 15, 2018 by Terry Walsh, Director APAC, MasterControl

    The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.

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  • Proving the Effectiveness of Mock FDA Audits

    May 10, 2018 by Patricia Santos-Serrao, Director of Product Strategy, MasterControl

    A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.

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  • How to Minimize Protocol Deviations

    May 1, 2018 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.

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  • Necessity Is the Mother of a Groundbreaking Validation Tool

    April 26, 2018 by Cindy Fazzi, Staff Writer

    It has been proven time and again that necessity is the mother of invention. From the printing press to electric cars, the story is similar. The printing press answered the need for a more rapid dissemination of information during the Renaissance, while the electric car is a response to the need for a zero-emission car today. In regulated environments, the dire need to lighten the software validation burden led to the development of a groundbreaking application.

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  • UK's MHRA Issues Final Guidance on GxP Data Integrity

    April 19, 2018 by Mark Schwartz, Director, Hyman, Phelps & McNamara

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • What, No Installation Records?

    February 27, 2018 by Christopher Joseph Devine, Ph.D., President, Devine Guidance International

    Christopher J. Devine delves into the topic of medical device installation recordkeeping, and why proper documentation of this process is essential to successfully installing medtech and avoiding warning letters and other mishaps.

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  • The Right EQMS for the Homeopathy Crackdown

    January 18, 2018 by Sarah Beale, Staff Writer

    For nutraceutical companies, recent headlines promising an FDA crackdown on homeopathic products were probably a bit unsettling. Traditionally the FDA hasn't been involved with homeopathy, but this new guidance means that companies will have to become compliant with these six risk-based categories.

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