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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 Hilde Viroux and Maggie Chan (PA Consulting) and Dona O’Neil (Northeastern University) | How can you be cost-effective in the face of the cost of compliance with the EU's Medical Device Regulation (MDR)? This article shares tips. |
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| Improving Toxicology Testing For Inhalation Products | Article | Battelle | By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs. |
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