An April 10 Manhattan Moment op-ed by Jared Meyer indicated that the Food and Drug Administration has inappropriately delayed access to and approval of a serogroup B meningococcal (or MenB) vaccine in the United States. This assertion is false. FDA is committed both to responding rapidly to public health threats and to approving products for serious medical conditions in a timely manner. While infections caused by MenB are uncommon in the U.S., they can be very serious. Under the FDAs expanded access program for investigational products, the agency has worked closely with the Centers for Disease Control and Prevention to make the unapproved MenB vaccine, Bexsero, available as quickly as possible for use on two college campuses. The expanded access program allows the use of an investigational drug, including a vaccine, that is not approved in the U.S. to treat or prevent serious or immediately life-threatening conditions when no comparable or satisfactory approved therapy is available. The FDA stands ready to work with CDC as needed moving forward. washingtonexaminer/fda-official-agency-is-committed-to-timely-approval-of-vaccines/article/2547421?custom_click=rss
Posted on: Sat, 19 Apr 2014 03:13:54 +0000
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