FDA Creates New Pharmacogenetics Websites, More

It's notorious that in November 2018 and in first-half 2019, the FDA had a number of aggressive tactics against pharmacogenetics laboratories.   (E.g. see background facts inside a recent February 14 report in Genomeweb, here.)  See also a Citizen's Petition filed against the FDA and its regulatory actions in mid-January, here and 19-page PDF document here.  (See similarly a deck about FDA at CPIC, the PGx consortium, here.)

On February 20, 2020, FDA released a long press release about new websites and initiatives at FDA regarding pharmacogenetic testing and reporting.

• See FDA press release here.
• See new FDA webpage for PGx associations - here.
• See the public comment docket here.
• FDA has been discussing whether or how it might joint a multi-stakeholder "collaborative community" on PGx - here.
• Article about FDA at RAPS, here.
• Article about FDA at Genomeweb, here.
• Article about FDA at Endpoints (echoes RAPS), here.
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• See separately a January 2020 article at Genomeweb about Translational Software, a vender of advanced PGx software, entering into the 510K process at FDA, here.
• Separately, CAP TODAY features PGX for February 2020 - here.