How Is AI Optimizing Different Aspects of FDA Submissions?

  • Ingenious E-Brain Solutions

The Department of Health and Human Services Regulatory agency is known as The Food and Drug Administration. The FDA is accountable for protecting and promoting public health through controlling and supervising food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, and medical devices. FDA approval is a must for any drug to be on the market. FDA plays a crucial role in reviewing drugs, medical devices, and biologics before it enters the market. The development of pharmaceuticals is a complex and lengthy process. Companies abide by the regulatory body’s guidelines for the effectiveness of the drugs, vaccines, biologics, and medical devices, for which FDA submission is essential and crucial in several steps. Nowadays, companies are leveraging artificial intelligence for effective and quick submissions. The FDA is also developing a new regulatory framework to promote innovation and support AI-based technologies. A New Strategy of the FDA in Leveraging AI: • In 2017, the FDA announced a ‘Digital Health Innovation Action Plan’ to outline its strategy to implement useful healthcare technologies and promote AI-based applications in research and development. Furthermore, the FDA is encouraging initiatives to develop and implement advanced predictive models in streamlining the drug review process. With an adequate regulatory framework, safe and effective therapies can be discovered, developed, and marketed much faster than ever. • Traditionally, the FDA evaluates medical devices through a suitable premarket pathway, such as De Novo classification or premarket approval. The FDA may also analyze and clear modifications to medical devices, including software as a medical device, depending on the importance of risk posed to patients by that modification. Learn the current FDA guidance for a risk-based approach for 510(k) software modifications. The FDA’s traditional medical device regulation paradigm was not intended for adaptive artificial intelligence and machine learning technologies. Under the FDA’s current approach to software changes, the FDA anticipates that many artificial intelligence and machine learning-driven software modifications to a device need a premarket review. • On April 2nd, 2019, the FDA issued a paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback.” This explains the FDA’s foundation for a possible way to premarket review for artificial intelligence and machine learning-driven software modifications. For more information, please visit @ https://www.iebrain.com/how-is-ai-optimizing-different-aspects-of-fda-submissions/ About Ingenious e-Brain Solutions: - Ingenious e-Brain Solutions provides high-quality, customized, and cost-effective Technology Intelligence, Business Intelligence, and Intellectual Property Intelligence solutions to industry leaders, and innovative companies across the globe. Innovation, knowledge, and transparency form the basis of our company’s mission and vision. Along with cost benefits, we provide highest quality results ensuring fool-proof confidentiality and security. We are an ISO certified company with offices in India and USA. Ingenious e-Brain Solutions has a strong team of analysts, and subject matter experts with domain proficiency which is devoted to help clients grow. Our highly qualified professionals offer tailored, value-added and cost-effective services to our clients. We believe in building long term relationships with our clients who include national and international corporations, Fortune 500 companies, world’s leading research institutes and universities as well as independent inventors. Get in Touch: - India Office 207-208 Welldone TechPark, Sohna Road Sector 48, Gurugram, Haryana 122018, India +91 124 429 4218 Email: - queries@iebrain.com