Various states enacted new prescription drug laws. Read more about Florida, Colorado, and Maryland here.
Lee Patrick2019-05-19T14:42:35-04:00Pilot FDA Program “Project Facilitate”Lee Patrick2019-05-19T14:42:35-04:00
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.
Lee Patrick2019-03-08T17:32:34-05:00Hidden FDA Reports Detail Harm Caused By Scores Of Medical DevicesLee Patrick2019-03-08T17:32:34-05:00
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 [...]
Lee Patrick2019-01-02T17:49:42-05:00New Breakthrough Device Designation Rule Finalized by the FDALee Patrick2019-01-02T17:49:42-05:00
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.
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