Regulatory Update — Week of Jan. 22, 2024

Over the past week, the FDA issued final guidance on revising ANDA labeling, draft guidances on metallic coatings and/or calcium phosphate coatings on orthopedic devices and conducting remote regulatory assessments. The agency also announced a meeting of the circulatory system devices panel of the medical devices advisory committee and posted best practices for FDA staff in postmarketing safety surveillance.
Source: Drug Industry Daily

Leave a Comment





This site uses Akismet to reduce spam. Learn how your comment data is processed.