Pharmaceutical and medical device manufacturers encounter constant threats and challenges. One serious threat is a breach of cybersecurity during the product life cycle and/or during postmarket management. Other challenges to industry include patient-focused drug development, labeling of biosimilars, and regulations for medical device software, among others. The FDA recently issued Guidance on Postmarket Management of Cybersecurity in Medical Devices. The FDA is also considering Guidance on other key regulatory drug and device issues. Register now for this informative webinar to learn from two top FDA regulatory lawyers who will assist you in better understanding these critical issues.
The application of FDA’s Guidance for Industry regarding Postmarket Management of Cybersecurity in Medical Devices
Regulatory issues facing drug and medical device companies in 2017
Possible additional areas of consideration for future FDA Guidance for Industry