FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Abram: Medical Countermeasures Initiative Has Signed Off on 121 Countermeasures

June 8, 2018

The FDA’s Medical Countermeasures Initiative cleared or licensed 121 medical countermeasures as of fiscal 2017, according to FDA Deputy Commissioner for Policy, Planning, Legislation and Analysis Anna Abram.

In testimony Wednesday before the House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act, Abram said the agency’s approvals and clearances included supplements to approvals, licensed and cleared medical products.

The MDMi initiative also issued more than 60 Emergency Use Authorizations since 2005, Abram said. Of these, nearly 40 were issued since 2013, including for major public health threats such as Ebola and Zika.

The agency also released a report Wednesday on the MDMi initiative for fiscal year 2017.

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