Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug substance-related impurities (NDSRIs) in...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