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| New FDA QMSR: Its Role in Part 4 Compliance for Combination Products | The FDA’s release of the new Quality Management System Regulation (QMSR) significantly revises 21 CFR Part 820 Quality System Regulation and, in turn, Part 4 CGMP for combination products. Join us on June 26th as experts discuss the history and intentions of the new QMSR and what it means for combination product manufacturers and areas of risk your organization may need to address. |
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By Susan Shockey, Clarkston Consulting | The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3. |
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| Combining Gene Therapies, Carrier Systems, And Medical Devices | Article | By Stefanie Johns, Ph.D., Kymanox Corporation | Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies. |
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| Building Sustainability Into Drug Delivery Devices | Article | Battelle | Medical device waste is a growing problem in the pharmaceutical industry. Learn how to navigate the balance between sustainability and factors like performance, safety, and regulatory compliance. |
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