Remember What Remains Unseen at the FDA

They will be blamed for the seen harms of a bad approval, but they will never be credited or condemned for the unseen harms ...

Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...
MobiHealthNews

FDA approval process too slow for wireless health

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...

FDA rejection sparks questions on Replimune drug approval path

Replimune Group Inc. REPL on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for ...

FDA approves new weight loss pill in record time

A new daily pill to help with weight loss has been approved by the U.S. Food and Drug Administration (FDA), and it moved through review faster than most drugs in recent years.
RAPS

Trump Criticizes ‘Slow and Burdensome’ FDA Approval Process

In a joint session of Congress on Tuesday evening, President Donald Trump repeated his attacks on the US Food and Drug Administration’s (FDA) “slow and burdensome approval process,” promising ...