Pilot FDA Program “Project Facilitate”

2019-05-19T14:42:35-04:00

The FDA has a pilot program called “Project Facilitate” that will handle requests for access to unapproved cancer drugs. They will connect patients and health care providers with contacts at pharmaceutical or biotechnology companies, complete request forms, and identify institutional review boards. Read more about this program here.

Pilot FDA Program “Project Facilitate”2019-05-19T14:42:35-04:00

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

2019-03-08T17:32:34-04:00

The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark. Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the [...]

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices2019-03-08T17:32:34-04:00

New Breakthrough Device Designation Rule Finalized by the FDA

2019-01-02T17:49:42-04:00

The Breakthrough Device designation, instituted in 2016, is meant for products that are intended to address or diagnose life-threatening or irreversibly debilitating conditions. 110 devices have received the designation and 8 products have received approval through the regulatory pathway since the program has been introduced. Read more about this development here.

New Breakthrough Device Designation Rule Finalized by the FDA2019-01-02T17:49:42-04:00
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