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 Orphan Diseases Partnering 2012-2018: Deal trends, players and financials
... since 2012. 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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Global Big Pharma Partnering Terms and Agreements 2012-2018: 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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Market Access, Pricing and Reimbursement of Oncology Medicines in the 5EU
... value assessments and economic pressures on national budgets and health systems. Although, 5EU markets have implemented patient access schemed to ensure early access to innovative oncology medicines with high unmet need, the increasing requirements for ... Read More
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PharmSource - Contract Dose Manufacturing Industry by the Numbers: Composition, Size, Market Share and Outlook - 2018 Edition
... that produce a client’s pharmaceutical finished dosage form for supply to the highly regulated markets of the US, Canada, EU, and Japan. The motivation for pharma companies outsourcing their manufacturing is often to do with ... Read More
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Partnerships, Licensing, Investments and M&A Deals and Trends for May 2018 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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Patient Registry Software Market By Type (Diabetes, Cancer, Rare Diseases, CVD, Orthopedic, Drugs, Device), Delivery (On Premise, Cloud), Functionality (PHM, POC, Research), Database (Public, Commercial), Pricing Model, End User – Global Forecast To 2023
... 2023 Patient Registry Software Market by Type (Diabetes, Cancer, Rare Diseases, CVD, Orthopedic, Drugs, Device), Delivery (On premise, Cloud), Functionality (PHM, HIE, POC, Research), Database (Public, Commercial), Pricing Model, End User - Global Forecast to ... Read More
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Global Orphan Drugs Market: Industry Analysis & Outlook (2018-2022)
... which affects a smaller share of population. Most of the rare diseases are genetic and therefore chronic. Presently, there are around 7000 rare diseases affecting approximately 5-6% of the global population. Half of the population ... Read More
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Pharmaceutical Contract Manufacturing Market 2018-2028
... the market in 2017. Visiongain estimated that the pharmaceutical contract manufacturing market will reach $93bn in 2022. How this report will benefit you Read on to discover how you can exploit the future business opportunities ... Read More
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Cannabis Production in Canada - Industry Market Research Report
... companies. This development has largely been shaped by the Canadian government's ongoing deregulation of medical marijuana consumption, as well as underlying demographic shifts and improving consumer conditions. And while the sale and consumption of non-medical ... Read More
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Global Healthcare Asset Management Market - Segmented by Technology, Component, Application, and Geography - Growth, Trends, and Forecasts (2018 - 2023)
... 2017. The market is expected to register a CAGR of 7.54% during the forecast period (2018 - 2023). North America accounted for the largest market, while Europe came next. Asia-Pacific is estimated to register the ... Read More
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Global and Chinese Photostability Chamber Industry, 2018 Market Research Report
... market. The report provides key statistics on the market status of the Photostability Chamber manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry.Firstly, the report provides ... Read More
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Global ePrescribing Market - Trends Analysis, Company Usability Profiles & Forecasts to 2024
... USD 2,532.56 million by the end of 2024, at a Compound Annual Growth Rate of 21.08%. Market Segmentation & Coverage: The report on global eprescribing market identifies key attributes about the customer to define the ... Read More
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Global Learning Management System Market - Trends Analysis, Company Usability Profiles & Forecasts to 2024
... system market globally” The global learning management system market is expected to grow from USD 6,146.78 million 2017 to USD 26,402.65 million by the end of 2024, at a Compound Annual Growth Rate of 23.15%. ... Read More
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Pharmaceutical Contract Packaging Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2018-2023
... 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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North America Closed System Transfer Device (CSTD) Market by Manufacturers, Countries, Type and Application, Forecast to 2022
... contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system, which designed to prevent the escape of hazardous drug vapors into the environment during drug reconstitution and administration. Scope ... Read More
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Global Pharmacovigilance Category - Procurement Market Intelligence Report
... adverse reactions that might have previously gone undetected. Additionally, the demand for the category is being driven by the increasing incidence of ADEs, the rise in ADEs in the geriatric population, and the increase in ... Read More
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PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2018 Edition
... the drug product CMO industry using NDA approvals as the primary indicator of performance. The report examines 118 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) in 2017 along with four ... Read More
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Global Healthcare CMO Market (2018-2022 Edition)
... provides the analysis of global healthcare CMO market by value and by segment. The analysis of global medical device CMO market is done by value, by players and by cost structure and analysis of global ... Read More
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Medical Affairs in Emerging Markets
... becoming increasingly complex with developments, such as the increasing use evidence-based prescribing, putting medical affairs (MA) teams under pressure. But in BRIC countries a one size fits all approach to MA will not cater for ... Read More
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Global Pharmacovigilance and Drug Safety Software Market - Segmented by Functionality, Mode of Delivery, End Users, and Geography - Growth, Trends, and Forecast (2018 - 2023)
... is projected to witness a CAGR of 6% during the forecast period of 2018–2023. Increasing Incidences of Adverse Drug Reactions (ADRs) Adverse drug reaction (ADR) refers to injuries arising from the consumption of medication. ADR ... 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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Global (North America, Europe and Asia-Pacific, South America, Middle East and Africa) Closed System Transfer Device (CSTD) Market 2017 Forecast to 2022
... prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system, which designed to prevent the escape of hazardous drug vapors into the environment during ... Read More
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Pharmaceutical Contract Manufacturing Market: Global Industry Analysis, Trends, Market Size and Forecasts up to 2024
... 2024. The report predicts the global pharmaceutical contract manufacturing market to grow with a CAGR of 6.25% over the forecast period of 2018-2024. The study on pharmaceutical contract manufacturing market covers the analysis of the ... Read More
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Asia-Pacific Closed System Transfer Device (CSTD) Market by Manufacturers, Regions, Type and Application, Forecast to 2022
... into a system and the escape of hazardous drug or vapor concentrations outside the system, which designed to prevent the escape of hazardous drug vapors into the environment during drug reconstitution and administration. Scope of ... Read More
