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2010, Princeton studies in American politics, ISBN 0691141800, xx, 802
The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield... 
Pharmaceutical policy | Drugs | United States. Food and Drug Administration | United States | Research | History | Political Science | Health Sciences | Public Policy | POLITICAL SCIENCE | HISTORY | Food and Drug Administration
Book
Journal of the American College of Cardiology, ISSN 0735-1097, 10/2017, Volume 70, Issue 18, pp. B148 - B148
Background The Colibri heart valve (CHV) is a pre-mounted, pre-packaged, low-profile, ready-for-use dry TAVR valve with conical cusp design mounted upon a... 
Feasibility studies | FDA approval
Journal Article
2010, ISBN 9780470170861, xxv, 630
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development:... 
Medical | Pharmacology | Clinical trials | Drug development
Book
The New England Journal of Medicine, ISSN 0028-4793, 02/2015, Volume 372, Issue 6, pp. 588 - 588
Interactive Perspective: Drug Development and FDA Approval, 1938–2013 (June 26, 2014;370:e39). The order of authors was incorrect; Dr. Darrow should have been... 
Drug development | FDA approval
Journal Article
JACC (Journal of the American College of Cardiology), ISSN 0735-1097, 2017, Volume 69, Issue 11, pp. 1692 - 1692
Background: The single-pill combination (SPC) comprising nebivolol (5 mg), a vasodilatory β1-selective antagonist/ β3 agonist, and valsartan (80 mg), an... 
Cardiovascular | Internal Medicine | Hypertension | FDA approval
Journal Article
Journal Article
The oncologist (Dayton, Ohio), ISSN 1083-7159, 12/2018, Volume 23, Issue 12, pp. 1520 - 1524
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to vemurafenib for the treatment of adult patients with... 
Vemurafenib | Zelboraf | Non‐Langerhans cell histocytosis | BRAFV600 mutations | Histiocytosis | Non-Langerhans cell histocytosis | Life Sciences & Biomedicine | Oncology | Science & Technology | Index Medicus | FDA | Regulatory Issues
Journal Article
The oncologist (Dayton, Ohio), ISSN 1549-490X, 12/2017, Volume 23, Issue 3, pp. 353 - 359
On March 30, 2017, the U.S. Food and Drug Administration (FDA) approved osimertinib for the treatment of patients with metastatic, epidermal growth factor... 
Epidermal growth factor receptor inhibitor | Osimertinib | T790M | Non‐small cell lung adenocarcinoma | Non-small cell lung adenocarcinoma | Life Sciences & Biomedicine | Oncology | Science & Technology | FDA | Regulatory Issues
Journal Article
The New England journal of medicine, ISSN 1533-4406, 04/2019, Volume 380, Issue 15, pp. 1450 - 1462
Journal Article