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 ...
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 ...

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 ...
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FDA unveils proposal for streamlined approval of customized drugs for rare diseases

Federal health officials in Washington announced a proposal on Monday aimed at accelerating the development of customized treatments for patients suffering from difficult-to-treat diseases, including ...

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.