USFDA Publishes updated definitions FOR ‘Face-to-Face Meeting’
The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.
United States’ FDA issues guidance on Pre-IND meetings during COVID-19
In an effort to support sponsors responding to the public health emergency of COVID-19 pandemic, On May 2020, the FDA provided a guidance to assist sponsors in preparing pre-IND meeting requests for COVID-19 related drugs (human drugs and biological products).
FDA Draft Guidance on Performance Criteria for Safety and Performance Based Pathway for Soft Daily Wear Contact Lenses
On March 4, 2020, US FDA published a new draft guidance to allow manufacturers of eligible daily wear soft (hydrophilic) contact lenses to use new performance criteria pathway to support substantial equivalence instead of a direct comparison of the performance of their device to that of a predicate device during 510(K0 submission