The Secrets We Keep — FDA Data Integrity, Elizabeth Holmes, Theranos, Bad Blood and HBO’s “The Inventor?”

Jack Garvey |

By now, most everyone in FDA regulated industry is aware of Theranos, the Wall Street Journal’s John Carryrou, and his award-winning book Bad Blood: Secrets and Lies Inside a Silicon Valley Startup. But have you seen HBO’s new... Read more

FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications

Tommy McMaster |

FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications Key elements of this Guidance: - FDA has not changed the requirements, per say. They have split the requirements so there is clarity... Read more

A Critical Guidance Has Been Issued – “Refuse to “Accept Policy for 510(k)s”

Tommy McMaster |

Our very own Teresa Gorecki took to LinkedIn earlier this afternoon to announce... A critical Guidance has been issued by FDA; the new Guidance, “Refuse to “Accept Policy for 510(k)s”, is now available on fda.gov. This is an... Read more