On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist laboratories and commercial manufacturers in development of diagnostic tests for the novel coronavirus (“COVID-19”) during the ongoing pandemic.
During the first week of implementation, questions arose regarding the extent to which the Emergency Use Authorization (“EUA”) pathway to market, as described by the Policy, covers at-home ...
Blog Editors
Recent Updates
- Breaking Down the Legal Challenges Surrounding State Licensure Restrictions for Telehealth Providers
- Interested in Opening a Medical Spa? Here’s What You Need to Know
- Podcast: Key Changes in Finalized Antitrust Merger Guidelines – Diagnosing Health Care
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
- Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams