FDA Approval

A written regulatory communication from FDA to an applicant, who submitted request to the agency to approve marketing or to license medical product… (More)
National Institutes of Health

Topic mentions per year

Topic mentions per year

2007-2017
051020072017

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2017
2017
of organ-specific cancers on the basis of tumor markers; in many instances, markers are used to select patients who may be more… (More)
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2017
2017
InMay2017, theUSFoodandDrugAdministration(FDA) announced a Drug Competition Action Plan, designed to address competition and… (More)
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2017
2017
  • Journal of managed care & specialty pharmacy
  • 2017
Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on… (More)
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Review
2017
Review
2017
RATIONALE AND OBJECTIVES To evaluate uptake, patterns of use, and perception of digital breast tomosynthesis (DBT) among… (More)
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2017
2017
The pitch begins like this: “Patients with #NameYourDisease represent a large market with a significant unmet medical need.” It… (More)
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2016
2016
The explosive growth of mobile technologies combined with the rapid rise of aging populations fearful of their risk for Alzheimer… (More)
  • table 1
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Review
2016
Review
2016
In the face of divergent views, we at the FDA think it’s important to clarify why flibanserin was approved after being rejected… (More)
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2015
2015
On December 3, 2014, the FDA granted accelerated approval of blinatumomab (Blincyto; Amgen, Inc.) for treatment of Philadelphia… (More)
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2015
2015
Interactive Perspective: Drug Development and FDA Approval, 1938-2013 (June 26, 2014;370:e39). The order of authors was incorrect… (More)
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2013
2013
1 CCR Perspectives in Drug Approval Abiraterone Acetate in Combination with Prednisone for the Treatment of Patients with… (More)
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