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INSIGHTS

News & Information about FDA Compliance

GDUFA REAUTHORIZED FOR 2018

GDUFA REAUTHORIZED FOR 2018

On August 18, 2017, the Food and Drug Administration Reauthorization Act (FDARA) was signed into law, which includes the reauthorization...

Featured Posts

FDA Publishes Final Refuse To Accept Guidance

FDA Publishes Final Refuse To Accept Guidance

Final Guidance Documents: When to submit new 510(k)s for devices and software

Final Guidance Documents: When to submit new 510(k)s for devices and software

GDUFA REAUTHORIZED FOR 2018

GDUFA REAUTHORIZED FOR 2018

U.S. FDA ANNOUNCES FY2018 USER FEES

U.S. FDA ANNOUNCES FY2018 USER FEES

Recent Posts

FDA Publishes Final Refuse To Accept Guidance

Final Guidance Documents: When to submit new 510(k)s for devices and software

GDUFA REAUTHORIZED FOR 2018