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The FDA said it has received “reports of pain and changes in the surrounding bone and soft tissue in people implanted with the Precice Stryde device.” Read More
The FDA shot down each of the requests in the petition, except a requested revision to draft guidance to clarify the definition of what are known as “free” and “bound” paclitaxel or albumin. Read More
She has held several prominent positions within the agency, including lead negotiator with industry for the FDA’s commitments under the Generic Drug User Fee Act (GDUFA) III. Read More