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Federal Register notice: FDA makes available a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Imp...[ Price : $8.95]
Federal Register notice: FDA announces a 1/26/2018 public hearing on its approach to evaluating the safety and efficacy of nicotin...[ Price : $8.95]
CDRH associate director for digital health Bakul Patel tells a webinar on precertification that the goal is a streamlined regulato...[ Price : $8.95]
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Journalism professor Charles Seife details ways in which he says FDA is withholding information about Sareptas Exondys 51 to prote...[ Price : $8.95]
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Merck KGaA and Pfizer report that the Phase 3 JAVELIN gastric cancer trial did not meet its primary endpoint of superior overall s...[ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Relypsas Veltassa (patirome...