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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Contract Research Organizations in the US - Industry Market Research Report
... for Food and Drug Administration (FDA) approval. An explosion in research and development investment, frustratingly high clinical trial costs and an uptick in patent expirations have driven pharmaceutical companies to outsource clinical trial management. These ... Read More
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Pharmacovigilance & Drug Safety Software Market by Product (Adverse Event Reporting Software, Drug Safety Audits Software, Fully Integrated Software), Clinical Trial (Phase I, Phase II, Phase III), Distribution, End User - Global Forecast 2024-2030
... Pharmacovigilance & Drug Safety Software Market size was estimated at USD 552.10 million in 2023 and expected to reach USD 629.31 million in 2024, at a CAGR 14.55% to reach USD 1,429.24 million by 2030. ... Read More
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Hepatitis Drugs Markets in China
... 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 trends, ... Read More
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Orphan Drugs Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032
... 170.49 billion in 2023, and the market is now projected to grow from USD 189.17 billion in 2024 to USD 468.58 billion by 2032, exhibiting a CAGR of 12.0% during the forecast period of 2024-2032. ... Read More
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Pharmacovigilance Market Share, Size, Trends, Industry Analysis Report, By Service, By Product Life Cycle, By Type, By Process Flow, By Therapeutic Area, By End-Use, By Region; Segment Forecast, 2024 - 2032
... size is expected to reach USD 13.75 Billion by 2032 according to a new study by Polaris Market Research. The report “Pharmacovigilance Market Share, Size, Trends, Industry Analysis Report, By Service, By Product Life Cycle, ... Read More
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2024 Testing Services for Pharmaceutical, Medical Devices, and Personal Care Products Global Market Size & Growth Report with Updated Recession Risk Impact
... Global Market Size & Growth Report covers market size, revenue, growth, and share across 4 global regions (The Americas, Europe, Asia & Oceania, Africa & Middle East), 22 subregions, and 195 countries. Figures are from ... Read More
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2024 Global Forecast for Pharmacovigilance Market (2025-2030 Outlook)-High Tech & Emerging Markets Report
... or service category is within the NAICS Medical Laboratories industry. The product or service category is within the NAICS Medical Laboratories industry. The global market is expected to increase from USD xx billion in 2025 ... Read More
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2024 Global Forecast for Pharmacovigilance And Drug Safety Software Market (2025-2030 Outlook)-High Tech & Emerging Markets Report
... 50 countries. The product or service category is within the NAICS Medical Laboratories industry. The product or service category is within the NAICS Medical Laboratories industry. The global market is expected to increase from USD ... Read More
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2024 Global Forecast for Pharmaceutical Sterility Testing Market (2025-2030 Outlook)-High Tech & Emerging Markets Report
... The product or service category is within the NAICS Medical Device Mfg. industry. The product or service category is within the NAICS Medical Device Mfg. industry. The global market is expected to increase from USD ... Read More
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2024 Global Forecast for Pharmaceutical Analytical Testing Outsourcing Market (2025-2030 Outlook)-High Tech & Emerging Markets Report
... countries. The product or service category is within the NAICS Medical Laboratories industry. The product or service category is within the NAICS Medical Laboratories industry. The global market is expected to increase from USD xx ... Read More
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Global Anti-Counterfeit Databank Market Report
... & Trace segment is expected to be the highest contributor to this market, with $71,792.0 Million in 2022, and is anticipated to reach $172,567.2 Million by 2031, registering a CAGR of 10.30%. Covert segment is ... Read More
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New Drug Approvals and Their Contract Manufacture - 2024 Edition
... performance. New Drug Approvals and Their Contract Manufacture (formerly called CMO Scorecard) is critical for benchmarking the performance of the contract manufacturing organization (CMO) industry and the relative performance of major CMOs. This year's edition ... Read More
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Pharmacovigilance Market Analysis And Forecast To 2033: By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, and Phase IV), Service Provider (In-house and Contract Outsourcing), Type of Reporting (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, and EHR Mining), End User (Pharmaceuticals, Biotechnology Companies, Medical Device Manufacturers, Others), And By Region
... Targeted Spontaneous Reporting, Cohort Event Monitoring, and EHR Mining), End User (Pharmaceuticals, Biotechnology Companies, Medical Device Manufacturers, Others), And By Region The global Pharmacovigilance Market was valued at 7.1 billion in 2023 and it is ... Read More
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2024 Global Forecast for Drug Testing (2025-2030 Outlook)-High Tech & Emerging Markets Report
... service category is within the NAICS Medical Laboratories industry. The product or service category is within the NAICS Medical Laboratories industry. The global market is expected to increase from USD xx billion in 2025 to ... Read More
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2024 Global: Bioanalytical Testing Services Market - Innovative Markets Forecast (2030) report
... the period 2019 through 2030. Perry/Hope Partners' reports provide the most accurate industry forecasts based on our proprietary economic models. Our forecasts project the product market size nationally and by regions for 2019 to 2030 ... Read More
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2024 Global Forecast for Bioanalytical Testing Services Market (2025-2030 Outlook)-High Tech & Emerging Markets Report
... product or service category is within the NAICS Medical Laboratories industry. The product or service category is within the NAICS Medical Laboratories industry. The global market is expected to increase from USD xx billion in ... Read More
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Life Sciences BPO Market Size, Trends, Analysis, and Outlook By Services (Pharmaceutical outsourcing, Medical devices outsourcing, Contract sales & market outsourcing, Others), By Pharmaceutical outsourcing (Contract manufacturing market, API, Finished dose form, Packaging, Contract research organizations, Drug discovery, Preclinical studies, Clinical trial studies, Regulatory services, Pharmacovigilance), By Medical devices outsourcing (Contract manufacturing market, Electronic manufacturing services, Finished goods, Raw materials, Contract research organizations, Regulatory consulting services, Product design and development services, Product testing services, Product implementation services, Product upgrade services, Product maintenance services), by Region, Country, Segment, and Companies, 2024-2030
... organizations, Drug discovery, Preclinical studies, Clinical trial studies, Regulatory services, Pharmacovigilance), By Medical devices outsourcing (Contract manufacturing market, Electronic manufacturing services, Finished goods, Raw materials, Contract research organizations, Regulatory consulting services, Product design and development ... Read More
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Pharmaceutical Regulatory Affairs Market Size, Trends, Analysis, and Outlook By Services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Others), By Drugs (Innovator, Generics), By Biologics (Biotech, ATMP, Biosimilars), By Indication (Oncology, Neurology, Cardiology, Immunology, Others), By Product Stage (Preclinical, Clinical studies, PMA), By Service Provider (In-house, Outsourcing), By Organisation Size (Small, Medium, Large), by Region, Country, Segment, and Companies, 2024-2030
... By Indication (Oncology, Neurology, Cardiology, Immunology, Others), By Product Stage (Preclinical, Clinical studies, PMA), By Service Provider (In-house, Outsourcing), By Organisation Size (Small, Medium, Large), by Region, Country, Segment, and Companies, 2024-2030 The global Pharmaceutical ... Read More
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Medical Affairs Outsourcing Market Size, Trends, Analysis, and Outlook By Services (Medical Writing & Publishing, Medical Monitoring, Medical Science Liaisons (MSLs), Medical Information, Others), By End-User (Pharmaceutical, Biopharmaceutical, Medical Devices), by Region, Country, Segment, and Companies, 2024-2030
... Companies, 2024-2030 The global Medical Affairs Outsourcing market size is poised to register 13.4% growth from 2024 to 2030, presenting significant growth prospects for companies operating in the industry. The industry study analyzes the global ... Read More
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Healthcare Contract Research Organization Market Size, Trends, Analysis, and Outlook By Type (Drug Discovery(Target Validation, Lead Identification, Lead Optimization), Pre-Clinical, Clinical), By Services (Project Management/Clinical Supply Management, Data Management, Regulatory/Medical Affairs, Medical Writing, Clinical Monitoring, Quality Management/ Assurance, Bio-statistics, Investigator Payments, Laboratory, Patient And Site Recruitment, Technology, Others), by Region, Country, Segment, and Companies, 2024-2030
... Quality Management/ Assurance, Bio-statistics, Investigator Payments, Laboratory, Patient And Site Recruitment, Technology, Others), by Region, Country, Segment, and Companies, 2024-2030 The global Healthcare Contract Research Organization market size is poised to register 7.16% growth from ... Read More
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The 2025-2030 World Outlook for Pharmacovigilance and Drug Safety Software
... the latent demand, or potential industry earnings (P.I.E.), for the country in question (in millions of U.S. dollars), the percent share the country is of the region, and of the globe. These comparative benchmarks allow ... Read More
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The 2025-2030 World Outlook for Pharma Track and Trace Solutions
... the latent demand, or potential industry earnings (P.I.E.), for the country in question (in millions of U.S. dollars), the percent share the country is of the region, and of the globe. These comparative benchmarks allow ... Read More
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The 2025-2030 World Outlook for Clinical Research Organizations (CROs)
... demand, or potential industry earnings (P.I.E.), for the country in question (in millions of U.S. dollars), the percent share the country is of the region, and of the globe. These comparative benchmarks allow the reader ... Read More
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The 2025-2030 World Outlook for Pharmacovigilance
... for the country in question (in millions of U.S. dollars), the percent share the country is of the region, and of the globe. These comparative benchmarks allow the reader to quickly gauge a country vis-à-vis ... Read More
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The 2025-2030 World Outlook for In-Vitro Toxicity Testing
... potential industry earnings (P.I.E.), for the country in question (in millions of U.S. dollars), the percent share the country is of the region, and of the globe. These comparative benchmarks allow the reader to quickly ... Read More
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