Tag Archives: FDA

Recent Support of Countermeasure Development Poised to Continue in Reauthorization of PAHPA

The U.S. Government has recently taken a number of steps to reinvigorate its support of medical countermeasure development. In particular, by pursuing new methods of contracting, updating regulatory frameworks, and establishing additional incentives for capital investment, the U.S. Government has confirmed that countermeasure development remains a critical component of public health preparedness. Now, over the … Continue Reading

FDA Commitment to MCM Development Reflected in New Draft Guidance on Medical Countermeasure Priority Review Vouchers

On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development and approval … Continue Reading

FDA Adopts Core NIST Framework in Guidance for Management of Cybersecurity in Medical Devices

The U.S. Food and Drug Administration recently became one of a number of federal agencies to adopt the National Institute of Standards and Technology’s (“NIST”) core cybersecurity framework.  On October 2, 2014, FDA issued final guidance on the content of premarket submissions for the management of cybersecurity in medical devices.  The final guidance sets forth … Continue Reading
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