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Communication between FDA and 23andMe can be found on FDA???s website going back to 2010, documenting FDA???s view that the PGS falls within the category of a regulated medical device requiring approval. Their recent Warning Letter cites ???more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications???providing specific feedback on requirements..and regulatory pathways [for approval/clearance]???. Most of this communication is not available to the public, so it is impossible to know the details of why 23andMe has not been able to secure FDA approval to date. Is the FDA being unreasonable with their requirements? Is 23andMe actually making meaningful efforts to comply? At this point, we simply don???t know. But FDA???s considerable time and resource spent working with 23andMe could be a sign of their desire to not only make personal genetic information available, but also of their commitment to ensuring that such sensitive, valuable information is accurate and reliable before people act on it.