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For this edition of the Protocol Link Newsletter, we take a look at a new initiative announced by the FDA, review environmental monitoring compliance hot topics, dive into the newly published ISO 9001:2015 standard, and review how Outsourcing Facilities are handling compliance under Section 503B.
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The Patient Preferences Initiative:
FDA Announces First-ever Patient Engagement Advisory Committee
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Christine Shumard-Sauer, Ph.D.
Director, Protocol Link
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On September 21st, the FDA officially announced a new initiative: the first-ever Patient Engagement Advisory Committee (PEAC). According to Nina Hunter, Ph.D., Regulatory Scientist in CDRH and Special Assistant for Medical Policy to the Office of Medical Products and Tobacco, and Robert Califf, M.D., Deputy Commissioner for Medical Products and Tobacco and FDA Commissioner nominee, FDA has launched this new initiative as a continued response to U.S. consumer needs as patients become much more active in their health care choices. What is unique about PEAC is that this committee is focused on patients, their experiences, and health-related goals as they pertain to medical devices. This is also known as "patient preferences", or those preferences expressed by patients with regard to decisions concerning their health care. The Agency expects that this committee will be able to provide advice to the FDA Commissioner on a range of complex issues relating to medical devices and their use by patients.
Read Entire Article
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Environmental Monitoring: Everything Old Is New Again
Dale Kelley
Senior Manager, Protocol Link
It's an old topic for those in the aseptic manufacturing space, a new area of focus for anyone in the sterile drug compounding or 503B Outsourcing space, and an ongoing question for terminally sterilized and non-sterile pharmaceutical, device, and combination product manufacturers. Did I mention that the FDA seems to be really interested (again) these days as well?
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ISO 9001:2015 Has Been
Published
Laura Spiegelhoff, MBA
Senior Project Manager, Protocol Link
The newly released ISO 9001:2015 standard was published on September 23, 2015. The standard has changed very significantly in the areas of risk management and management responsibility, and carries other substantive changes throughout the body of the standard.
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Registered Outsourcing Facilities:
We've come a long way, but we're not there yet...
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Daniel J. Hoch, Ph.D.
Vice President, Protocol Link
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 Congress passed the DQSA in November 2013. Its inception originated from the catastrophic events of late 2012, when contaminated compounded steroid injections made by a Compounding Center caused a fungal meningitis outbreak leading to infections in more than 750 individuals and the deaths of 64 people across 20 states. While the compounding center had been inspected by the FDA, the agency claimed that their failures to circumvent this issue were related to enforcement limitations it faced under provisions in the Food, Drug, and Cosmetic Act.
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The continued wave of company mergers and acquisitions in our global FDA-regulated industry has put a premium on companies who are expert in program management and technical transfer.
Products, methods, equipment, processes, labeling, and quality/data systems are moving, changing, consolidating, and/or being newly created in order to provide continuity of supply to the marketplace as transparently as possible.
We know that the 'devil is in the details' for effectively managing these activities and have found that a systematic process is key to meeting both integration / implementation deadlines and regulatory requirements. I'm proud of our proven talents in these critically important areas of service and we will continue to expand them significantly for our clients in the years ahead.
Steven Weltler
President, Protocol Link
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