Category: Regulations
-
Univ. Lab to Offer Large-Scale Covid-19 Testing
A University of Maryland lab will seek FDA authorization for its plan to provide high-volume detection testing for Covid-19 infections among state citizens.
-
Venture-Backed Start-Ups to Get Small Biz Loans
An industry group says rules for loans to small companies hard-hit by Covid-19 are changed to allow these loans for more start-ups funded by venture capital.
-
Employers, Patients See Discounts from Biosimilars
An analysis of health care spending by large employers shows both companies and their employees are saving money from using non-branded biologic therapies.
-
Prescription Insomnia App Okayed by FDA
A mobile app prescribed by physicians to treat chronic insomnia is cleared by the Food and Drug Administration for marketing in the U.S.
-
Trial to Test Arthritis Drug for Covid-19 Pneumonia
A clinical trial is beginning soon that tests a current drug for rheumatoid arthritis as a treatment for severe pneumonia in patients with Covid-19 infections.
-
FDA Okays Faster Covid-19 Test, Nixes Home Tests
The Food and Drug Administration granted an emergency clearance for a point-of-care test to detect for the virus causing novel coronavirus or Covid-19 infections.
-
FDA Outlines Trial Disruption Steps Due to Covid-19
The Food and Drug Administration outlined steps clinical trial teams should take if their studies face disruptions from the novel coronavirus, or Covid-19, pandemic.
-
FDA Clears High-Volume Covid-19 Test
The Food and Drug Administration cleared for use in the U.S. a high-volume diagnostic for the novel coronavirus that can run on automated systems already in place.
-
FDA Okays MRI with Epilepsy Brain Stimulation
A company making brain stimulation systems to treat epilepsy received regulatory clearance for MRI scans in people with its implanted devices.
-
Skin Cancer Apps Shown Misleading, Unreliable
A review of smartphone apps that photograph and purport to analyze skin conditions for signs of cancer shows the apps are unreliable in detecting cancer.