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 Key elements of this Guidance: - FDA has not changed the requirements, per say. They have split the requirements so there is clarity... Read more

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