Provision Consulting GroupJun 9, 20211 minFDA NewsSouth Korea's Response to COVID-19Picture from www.fda.gov/media/149334/download The FDA's Center for Devices and Radiological Health (CDRH) has issued a report that...
Provision Consulting GroupMay 28, 20211 minFDA NewsOTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees WebinarThe questions regarding Over-The-Counter Monograph Drug User Fee from related establishments have been radically increasing. The FDA is...
Provision Consulting GroupMay 26, 20212 minFDA NewsFDA Warns Not Using Certain Needles With Safety Devices Made by HAIOU The U.S. Food and Drug Administration on Thursday asked healthcare providers to stop using certain syringes and needles manufactured by...
Provision Consulting GroupMay 19, 20212 minFDA NewsFDA authorizes use of the Pfizer-BioNTech Covid Vaccine in adolescents ages 12 to 15On May 10, 2021, the U.S. Food and Drug Administration permits the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in kids ages 12...
Provision Consulting GroupMay 5, 20213 minFDA NewsFDA Approves Treatment for Chronic Kidney DiseaseOn April 3, 2021, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney...
Provision Consulting GroupApr 15, 20212 minFDA NewsJoint CDC and FDA Statement on Johnson & Johnson COVID-19 VaccineThe following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr....