 The Case for Quality: Beyond Design Controls
Christine Shumard-Sauer, Ph.D--Director, Protocol Link
On October 10, 2017, the FDA will hold a Public Workshop on a new initiative,Voluntary Medical Device Manufacturing and Product Quality Program. The program is intended to allow the FDA to identify device manufacturers that consistently produce high-quality devices; by doing so, allowing the Agency to better focus their resources helping other manufacturers raise their level of quality. This program is also intended to help the FDA identify and promote practices that support consistent quality manufacturing, and align their regulatory, enforcement, compliance approaches with those practices.
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Regulatory Submission Update: New eCTD v4.0 Specification
Ankit Patel--Director, Protocol Link
The current Electronic Common Technical Document (eCTD) v3.2.2 is well established and has been in use by companies, software vendors, and the global industry. However, over the past few years, the eCTD has matured and acquired lots of moving parts to ensure that the submission meets the specific requirements established by the International Council for Harmonisation (ICH). In January 2017, ICH updated to eCTD v4.0 for Modules 2 through 5.
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 "Cures" Law Improves FDA Regulatory Process
Lokesh Kukreja, Ph.D--Sr. Scientist, Protocol Link
Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA) recently spoke about how the agency is taking the necessary steps to implement "The 21st Century Cures Act." The Cures Act, signed into a law on December 13, 2016, provides the FDA with tools to modernize regulatory programs by speeding up medical product development and bringing new treatments to patients faster and more efficiently. The law authorized $500 million in new funding for the next nine (9) years to help the FDA implement this plan. In his recent letter on the FDA Voice blog, Dr. Gottlieb highlighted some of the deliverables as part of the detailed work plan submitted to Congress this past June.
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A Word From Our Staff...
"I think of myself as a scientist; more precisely a Pharmaceutical Microbiologist. Applying scientific methods to problems, puzzles, investigations, and finding solutions really excites me. One of the things that I enjoy most about being an employee of Protocol Link is helping clients with new and different challenges. It's the same kind of excitement I experienced recently when I saw my first total eclipse of the sun. It wasn't just the two and a half minutes of awe inspiring totality, but the two hours or so before that we
spent with fellow viewers
in anticipation. Talking with others as they set up telescopes and cameras, discussing
strate
gies to get the best pictures,
and sharing the excitement with amateur astronomers who had
traveled from the UK to Paducah, Kentucky to watch. Then, there was the sharing of photos after and starting the plan for where to go in seven years! In very much the same way, the excitement of new cures, new diagnostic tools, unique processes, or a better way to make something pulls me in every time. It may not always be quite as exciting as the eclipse, but it keeps me coming back to where the action is with our clients."
Dale Kelley
Director, Protocol Link
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