FDA Releases the Status of Post-Market Studies

Recently, accelerated approval of drugs and other expedited approval programs have been questioned widely since they rely on limited pre-market evidence for approval and extended post-market commitments. It has been speculated that companies may not meet their post-market commitments in a timely fashion, if at all, and that the FDA may not enforce the post-market … Read more

Devices Pretending to be Medical Devices on Amazon, and FDA is Helpless.

The FDA made a public announcement this week asking consumers to not use anti-chocking devices, saying that they are not effective and that manual anti-choking procedures are much better. Anti-choking devices are popular, particularly with parents trying to be prepared for accidental choking of their children. However, the lack of FDA enforcement highlights the limits … Read more