The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
12/24/2021
/ 510(k) RTA ,
Abbreviated New Drug Application (ANDA) ,
CDRH ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Moderna Inc. ,
Pfizer ,
Pharmaceutical Industry ,
Prescription Drugs ,
R&D ,
Supply Chain ,
Vaccinations