Regulation & Policy Market Research Reports & Industry Analysis
In the United States drugs, diagnostics and medical devices are regulated by the Food and Drug Administration (FDA). The FDA is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA derives its power from the Food, Drug and Cosmetic Act,[7] (Passed in 1938 and amended since) and are codified in Title 21, Chapter 9 of the United States Code. Some other laws that impact the FDA’s authority is Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act.
Regulation & Policy Industry Research & Market Reports
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Global Big Pharma Partnering Terms and Agreements 2014-2019: Deal trends, players and financials
... companies enter Big Pharma partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes. This report provides details of the latest Big Pharma agreements announced in the ... Read More
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Emerging Pharmaceuticals Industry Forecasts - China Focus
... the manufacturing capabilities and rising consumer consumptions in China have transformed China’s society and economy. China is one of the world’s major producers for industrial and consumer products. Far outpacing other economies in the world, ... Read More
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Emerging Pharmaceuticals Markets in China
... economy maintains a high speed growth which has been stimulated by the consecutive increases of industrial output, imports & exports, consumer consumption and capital investment for over two decades. This new study examines China's economic ... Read More
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Orphan Drugs Market by Product and Geography - Global Forecast and Analysis 2019-2023
... also considers the sales of orphan drugs in Asia, Europe, North America, and ROW. In 2018, the biologics segment had a significant market share, and this trend is expected to continue over the forecast period. ... Read More
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Partnerships, Licensing, Investments and M&A Deals and Trends for May 2019 in Pharmaceuticals
... data and trend analysis on partnerships, licensing, mergers and acquisitions (M&As) and financings in the pharmaceuticals industry. The report provides detailed information on partnership and licensing transactions, M&As, equity/debt offerings, private equity, and venture financing ... Read More
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Cancer Treatment Drugs Markets in China
... The Chinese economy maintains a high speed growth which has been stimulated by the consecutive increases of industrial output, import & export, consumer consumption and capital investment for over two decades. This new study examines ... Read More
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Life Science Analytics Market by Type (Predictive, Descriptive, Prescriptive), Application (Marketing, Compliance, R&D, Pharmacovigilance, SCM), Component (Software, Service), Delivery (On Premise, Cloud), End User - Global Forecast to 2024
... improved data standardization, and the growing adoption of analytics solutions in clinical trials are the key factors driving the life science analytics market.” The life science analytics market is projected to reach USD 33.2 billion ... Read More
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Global Pharmacovigilance and Drug Safety Software Market 2019-2023
... of adverse drug events and pharmacovigilance data. Technavio’s pharmacovigilance and drug safety software market analysis considers sales from end-users pharmaceutical and biotechnology companies, contract research organization, and business process outsourcing. Our analysis also considers the ... Read More
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Pharmacovigilance Market Size, Outlook and Growth Opportunities, 2019- 2025
... Service Provider( In House, and Contract & Outsourcing), By Reporting Type( Trageted Spontaneous Reporting, Cohort Event Monitoring, Spontaneous Reporting, Intensified ADR Reporting, and EHR Mining), By End-User( Hospitals and Clinics, Pharamaceuticals Companies,and Others), and By ... Read More
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Hepatitis Drugs Markets in China
... economy maintains a high speed growth which has been stimulated by the consecutive increases of industrial output, import & export, consumer consumption and capital investment for over two decades. This new study examines China's economic ... Read More
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Brazil
... information and analysis on the healthcare, regulatory and reimbursement landscape in Brazil. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Brazil. ... Read More
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Pharmaceutical Contract Packaging Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024
... pharmaceutical packager provides services, facilities and equipments which range from designing drug packaging to the testing of the packaged drug. Pharmaceutical companies contract the packaging firms for secondary functions as it is more flexible, profitable ... Read More
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Global Pharmacovigilance and Drug Safety Software Market - Growth, Trends, and Forecast (2019 - 2024)
... safety software market. ADRs cause considerable mortality and morbidity worldwide. According to research estimates, approximately 5% of all hospital admissions in Europe are caused by ADRs. Furthermore, factors like increasing adoption of pharmacovigilance software by ... Read More
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Spain
... information and analysis on the healthcare, regulatory and reimbursement landscape in Spain. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Spain. ... Read More
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Orphan Drugs
... Rest of World. Annual estimates and forecasts are provided for the period 2016 through 2024. Also, a five-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary ... Read More
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Global Orphan Diseases Partnering 2014-2019: Deal trends, players and financials
... since 2014. Trends in Orphan Diseases partnering deals Financial deal terms for headline, upfront and royalty by stage of development Orphan Diseases partnering agreement structure Orphan Diseases partnering contract documents Top Orphan Diseases deals by ... Read More
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Contract Research Organizations - Industry Market Research Report
... has experienced a period of aggressive growth over the five years to 2019, benefiting from rapidly increasing research and development expenditures. As a result, industry revenue is expected to grow during the period. Despite a ... Read More
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Global Healthcare CMO Market (2019-2023 Edition)
... includes market size in terms of value, and market share by segments. A comprehensive segment analysis has also been provided in the report with their historical and forecasted value. This report also provides the analysis ... Read More
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PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2019 Edition
... the primary indicator of performance. CMO Scorecard is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs. Scope This 50-page report gives important, expert insight you won’t find ... Read More
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Germany
... information and analysis on the healthcare, regulatory and reimbursement landscape in Germany. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Germany. ... Read More
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Pharmacovigilance Market - Growth, Trends, and Forecast (2019 - 2024)
... drug toxicity, and increasing trend of outsourcing pharmacovigilance services. The increasing incidence of lifestyle diseases, such as diabetes, hypertension, and cardiac disorders, as a result of sedentary lifestyles, lack of physical activities, changing lifestyle patterns, ... Read More
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India
... information and analysis on the healthcare, regulatory and reimbursement landscape in India. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of India. ... Read More
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Review of Influence: The Institute for Clinical and Economic Review (ICER)
... novel and inclusive work on the value of drugs, using its own value framework and assessing the affordability, and even going so far as setting the value-based price benchmark of new drugs, has given payers ... Read More
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Pharmaceutical Contract Management Consulting in the US - Industry Market Research Report
... develop tools that evaluate Medicaid and Medicare reimbursements. Over the past five years, the patent cliff, an ongoing series of expiration dates for the patents on blockbuster drugs, has stimulated the volume of research and ... Read More
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Pharmaceuticals Markets in China
... a high speed growth which has been stimulated by the consecutive increases of industrial output, import & export, consumer consumption and capital investment for over two decades. This new study examines China's economic trends, investment ... Read More
