Medical Devices
FDA OKs Somryst Prescription Digital Therapeutic
FDA authorizes Pears Somryst prescription-only digital therapeutic intended to treat chronic insomnia in adults age 22 and older.
Medical Devices
FDA Says Digital Health Policies Help Covid-19 Solutions
FDA says it does not regulate as medical devices many digital health solutions used by public health officials and the public to manage response to Co...
Medical Devices
Comments on AI Used in Radiological Imaging
FDA extends the comment period on a 2/25-26 public workshop on artificial intelligence in radiological imaging.
Human Drugs
FDA Ends Clinical Data Summary Pilot
CDER ends its clinical data summary pilot program.
Human Drugs
Stimulus Bill Includes New OTC Drug User Fees
The coronavirus-related economic stimulus legislation includes language to allow FDA to create a new user fee program for over-the-counter drugs.
Human Drugs
Rescind Remdesivir Orphan Designation: Gilead
Gilead asks FDA to rescind its orphan drug designation of the companys remdesivir as a potential treatment for Covid-19.
Biologics
HCT/Ps Issues at California IVF Fertility Center
FDA warns California IVF Fertility Clinic about significant deviations from HCT/Ps regulations.
Medical Devices
Immediately-in-effect Guidance on Face Masks, Respirators
FDA issues an immediately-in-effect guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-2019 (COVID-19) Public ...
Biologics
Moderna Covid Vaccine SEC Filing
Moderna tells the SEC its clinical trial of a potential Covid-19 vaccine is proceeding according to protocol and could be offered to healthcare worker...
Human Drugs
Alston Bird FDA Domestic Inspection Analysis
Alston Bird attorneys say the drug industry must be prepared for FDA to creatively use existing authorities instead of physical inspections to ensure ...
