GDUFA REAUTHORIZED FOR 2018
On August 18, 2017, the Food and Drug Administration Reauthorization Act (FDARA) was signed into law, which includes the reauthorization...
U.S. FDA ANNOUNCES FY2018 USER FEES
The #USFDA just announced its #UserFees for FY2018, and there are some MAJOR increases. If your company is planning to submit a 510(k) or...