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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... 
Drugs | United States. Food and Drug Administration | Research | Pharmaceutical policy | United States | History | Political Science | Health Sciences | Public Policy | POLITICAL SCIENCE | HISTORY | Food and Drug Administration
Book
2008, 2nd ed., Drugs and the pharmaceutical sciences, ISBN 9781420070422, Volume 185., x, 469
.... It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices... 
Drugs | standards | Guideline Adherence | Legislation, Drug | Law and legislation | Pharmacy | Pharmaceutical Preparations | legislation & jurisprudence | Pharmaceutical Manufacturing | Pharmaceutical Science Regulatory | Analysis & Pharmaceutical Quality | United States
Book
2009, 5th ed., Drugs and the pharmaceutical sciences, ISBN 9781420088496, Volume 190, xviii, 529
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched... 
Drugs | standards | Gevernment policy | Drug Evaluation | Clinical Trials as Topic | New products | Drug approval | Government policy | Testing | Clinical Trials - Pharmaceutical Science | Pharmaceutical Science Regulatory | Drug Design & Development | United States | Standards
Book
Journal Article
Drugs (New York, N.Y.), ISSN 0012-6667, 02/2016, Volume 76, Issue 2, pp. 263 - 273
Journal Article
Drugs, ISSN 0012-6667, 8/2017, Volume 77, Issue 12, pp. 1369 - 1376
...), resulting in enhanced T-cell responses against cancer cells. The US FDA has granted durvalumab accelerated approval for the treatment of patients with locally advanced... 
Pharmacotherapy | Internal Medicine | Medicine & Public Health | Pharmacology/Toxicology | POPULATION | PD-L1 ANTIBODY | NAIVE PATIENTS | SAFETY | TOLERABILITY | TREMELIMUMAB | PHARMACOLOGY & PHARMACY | TOXICOLOGY | JAPANESE PATIENTS | MEDI4736 | COMBINATION | PHASE-I | United States | Humans | Antibodies, Monoclonal - adverse effects | Antibodies, Monoclonal - therapeutic use | Antineoplastic Agents - therapeutic use | Clinical Trials as Topic | Drug Approval | Urothelium - pathology | Antibodies, Monoclonal, Humanized | Urologic Neoplasms - drug therapy | Antineoplastic Agents - adverse effects | Antineoplastic Combined Chemotherapy Protocols - therapeutic use | Carcinoma, Transitional Cell - drug therapy | United States Food and Drug Administration | Intravenous administration | PD-1 protein | Lung cancer | Clinical trials | Cytotoxicity | Lymphocytes T | Metastasis | Cancer therapies | Metastases | Receptors | Human papillomavirus | Platinum | Urothelial carcinoma | Medical research | Squamous cell carcinoma | Head | Small cell lung carcinoma | Hematology | Melanoma | Non-small cell lung carcinoma | CD80 antigen | T cell receptors | Lung carcinoma | FDA approval | Gene expression | Bladder cancer | Chemotherapy | Cell death | Medical prognosis | Monoclonal antibodies | Head and neck cancer | Ligands | Solid tumors | Tumors | Apoptosis | Cancer
Journal Article
Drugs, ISSN 0012-6667, 9/2018, Volume 78, Issue 14, pp. 1509 - 1516
Journal Article
The New England journal of medicine, ISSN 1533-4406, 2014, Volume 371, Issue 8, pp. 689 - 691
In considering the approval of bedaquiline, the FDA weighed the benefits of treatment for patients with smear-positive, multidrug-resistant pulmonary tuberculosis, for whom there are insufficient... 
MEDICINE, GENERAL & INTERNAL | Diarylquinolines - therapeutic use | Humans | Female | Male | Mycobacterium tuberculosis - isolation & purification | Antitubercular Agents - therapeutic use | Tuberculosis, Multidrug-Resistant - drug therapy | Drug approval | Care and treatment | Tuberculosis | FDA approval | Drug resistance | Drug therapy | Pharmaceuticals
Journal Article
Drugs (New York, N.Y.), ISSN 0012-6667, 02/2016, Volume 76, Issue 2, pp. 275 - 281
.... Intravenous daratumumab was recently approved via an accelerated approval programme in the USA for patients with multiple myeloma who have received at least three prior lines of therapy including... 
MONOTHERAPY | LENALIDOMIDE | CD38 | PHARMACOLOGY & PHARMACY | TOXICOLOGY | COMBINATION | MULTIPLE-MYELOMA CELLS | Antibodies, Monoclonal - therapeutic use | Multiple Myeloma - drug therapy | Antineoplastic Agents - therapeutic use | Antineoplastic Combined Chemotherapy Protocols - therapeutic use | Humans | Clinical Trials, Phase II as Topic
Journal Article
Drugs (New York, N.Y.), ISSN 0012-6667, 01/2016, Volume 76, Issue 1, pp. 155 - 158
Journal Article
Journal Article
Drugs (New York, N.Y.), ISSN 0012-6667, 01/2018, Volume 78, Issue 1, pp. 139 - 145
...))) for the treatment of various haematological and solid malignancies. The drug has received accelerated approval from the US FDA for the treatment of mantle cell lymphoma based... 
CHRONIC LYMPHOCYTIC-LEUKEMIA | PHARMACOLOGY & PHARMACY | TOXICOLOGY | Protein-Tyrosine Kinases - metabolism | United States | Humans | Pyrazines - administration & dosage | Antineoplastic Agents - therapeutic use | Drug Approval | Pyrazines - therapeutic use | Antineoplastic Agents - administration & dosage | Protein Kinase Inhibitors - adverse effects | Dose-Response Relationship, Drug | Benzamides - administration & dosage | Benzamides - therapeutic use | Antineoplastic Agents - adverse effects | Adult | Antineoplastic Agents - pharmacology | Benzamides - pharmacology | United States Food and Drug Administration | Antibodies, Monoclonal, Humanized - therapeutic use | Lymphoma, Mantle-Cell - drug therapy | Treatment Outcome | Protein Kinase Inhibitors - administration & dosage | Protein Kinase Inhibitors - therapeutic use | Agammaglobulinaemia Tyrosine Kinase | Protein Kinase Inhibitors - pharmacology | Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy | Pyrazines - pharmacology | Protein-Tyrosine Kinases - antagonists & inhibitors | Tyrosine | Plasma | Regulatory agencies | Phosphorylation | Chronic lymphatic leukemia | Hematology | Leukemia | Metastasis | FDA approval | Kinases | Cancer therapies | Lymphoma | Bruton's tyrosine kinase | Mantle cell lymphoma | Response rates | Lymphomas | Mantle | Drug dosages | Protein-tyrosine kinase | Pharmaceuticals
Journal Article