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 ...

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 ...
RAPS

Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

Biotech is in a high-stakes game. RFK Jr.’s FDA keeps changing the rules.

Biotech has never been for the faint of heart. It’s a roll-of-the-dice proposition in which companies spend upward of a ...
Healio

When aiming for FDA approval, 'fight' when you are right

Please provide your email address to receive an email when new articles are posted on . John P. Berdahl, MD, said that finding success with the FDA requires clear agreement on a study’s purpose and ...