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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 | Drug Evaluation | Clinical Trials as Topic | New products | Drug approval | Government policy | Standards | Testing | Clinical Trials - Pharmaceutical Science | Pharmaceutical Science Regulatory | Drug Design & Development | United States
Book
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... 
Pharmacology & Pharmacy | Toxicology | Life Sciences & Biomedicine | Science & Technology | 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
Drugs (New York, N.Y.), ISSN 0012-6667, 2018, Volume 78, Issue 17, pp. 1829 - 1834
...Drugs (2018) 78:1829–1834 https://doi.org/10.1007/s40265-018-1004-5 ADISINSIGHT REPORT Fremanezumab: First Global Approval Sheridan M. Hoy 1 Published online... 
Pharmacology & Pharmacy | Toxicology | Life Sciences & Biomedicine | Science & Technology | Headache | Enzymes | Peptides | Migraine | Headaches | Neuropeptides | FDA approval | Regulatory approval | Studies | Prevention | Calcitonin gene-related peptide | Pain | Calcitonin | Response rates | Monoclonal antibodies | Clusters | Adults | Agreements | Pharmaceuticals
Journal Article
2008, 2nd ed., Drugs and the pharmaceutical sciences, ISBN 0849391849, Volume 181, x, 278
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st... 
Drugs | standards | United States. Food and Drug Administration | Laboratories | Drug Industry | Drug Approval | Research | Pharmaceutical Science Regulatory | Drug Design & Development | Analysis & Pharmaceutical Quality
Book
2004, Drugs and the pharmaceutical sciences, ISBN 9780824754655, Volume 141., xix, 596
... unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the 
Drugs | Technology, pharmaceutical | Drug approval | Government policy | Standards | Testing | Pharmaceutical Science Regulatory | Drug Design & Development | Drug development
Book
Clinical cancer research, ISSN 1078-0432, 10/2017, Volume 23, Issue 19, pp. 5994 - 5994
Journal Article
Journal Article
Journal Article
Academy of Management journal, ISSN 0001-4273, 08/2013, Volume 56, Issue 4, pp. 923 - 944
.... Focusing empirically on the United States Department of Agriculture's (USDA) approval of genetically modified organisms (GMOs... 
Business & Economics | Social Sciences | Management | Business | Agricultural industry | Influence | Administrative agencies | Powers and duties | Analysis | Studies | Organization theory | Business government relations | Decision making models | Regulatory approval | Impact analysis
Journal Article