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Will FDA/CMS Parallel Review Idea Make Headway This Time?
The possibility of simultaneous FDA and CMS evaluations of new health products is back in the front of agency officials' minds after a series of fits and starts over the past several years, says CMS Chief Medical Officer Barry Straube
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.
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Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.
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The newly issued Make America Healthy Again strategy report suggests that FDA leaders are doing a good job of feeding ideas to the Trump Administration, rather than having the agency agenda dictated from above.