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The Senate will continue debate on an omnibus FDA user fee bill, S. 3187, Wednesday, with discussion focusing on how many amendments to allow onto the floor for debate.
Generic-drug makers are contributing to review delays because, intentionally or not, their ANDAs too often fail to provide a full list of personnel and facilities involved in drug manufacturing and testing, FDA officials say.
Drugmakers would need to include sales prices of shortage drugs in pedigrees transmitted to buyers under a new House bill designed to stop “gray market” sales of drugs in short supply.
An FDA reviewer is recommending against approval of Pfizer’s neurodegenerative disorder treatment Vyndaqel, saying it failed to meet statistical significance in a single study.
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