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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Pharmaceutical Contract Management Consulting in the US - Industry Market Research Report
... patents on blockbuster drugs, has stimulated the volume of research and development (R&D) work outsourced by generic pharmaceutical and biotechnology companies, promoting growth for consultants. The outbreak of COVID-19 led to growth for consultants as ... Read More
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Pharmacovigilance
... of 9.2% over the analysis period 2023-2030. Contract Outsourcing, one of the segments analyzed in the report, is expected to record a 11.1% CAGR and reach US$12.3 Billion by the end of the analysis period. ... Read More
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Bioanalytical Testing Services
... by 2030, growing at a CAGR of 7.0% over the analysis period 2023-2030. Small Molecule Type, one of the segments analyzed in the report, is expected to record a 7.6% CAGR and reach US$4.7 Billion ... Read More
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Pharmaceutical Analytical Testing Outsourcing
... reach US$16.3 Billion by 2030, growing at a CAGR of 6.8% over the analysis period 2023-2030. Bioanalytical Testing Service, one of the segments analyzed in the report, is expected to record a 8.0% CAGR and ... Read More
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Orphan Drugs
... at a CAGR of 11.9% over the analysis period 2023-2030. Biologic Drugs, one of the segments analyzed in the report, is expected to record a 12.7% CAGR and reach US$286.3 Billion by the end of ... Read More
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Al in Biotechnology Market by Function (Drug Design & Optimisation, Biomarker, SAR; Clinical Trial Design, Data Assessment, RWE, Inventory, Supply chain, Logistics; Launch, Pricing, Patient Engagement, Adverse Events), & End User - Global Forecast to 2029
... 2029 The global AI in biotechnology market is projected to reach USD 7.75 billion by 2029 from USD 3.23 billion in 2024, at a high CAGR of 19.1% during the forecast period. The market is ... Read More
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Life Science Analytics Market by Type (Descriptive, Prescriptive, Predictive), Service (Analytics), Application (Drug Discovery, Trials, RWE, Access, Sales & marketing, Drug Safety), End User (Pharma, Medical Device), & Region - Global Forecast to 2029
... global Life science analytics market is projected to reach USD 61.94 billion by 2029 from USD 35.69 billion in 2024, at a CAGR of 11.7% during the forecast period. The market is expected to grow ... Read More
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Alpha 1 Antitrypsin Deficiency Treatment
... is expected to reach US$4.2 Billion by 2030, growing at a CAGR of 9.0% over the analysis period 2023-2030. Augmentation Therapy, one of the segments analyzed in the report, is expected to record a 9.7% ... Read More
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Pharmacovigilance Outsourcing Market: Global Market Size, Forecast, Insights, Segmentation, and Competitive Landscape with Impact of COVID-19 & Russia-Ukraine War
... 2025-2034. This report on global pharmacovigilance outsourcing market report provides holistic understanding of the market along with market sizing, forecast, drivers, challenges, and competitive landscape. The report presents a clear picture of the global pharmacovigilance ... Read More
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Emerging Pharmaceuticals Industry Forecasts - China Focus
... 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, China ... Read More
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Pharmacovigilance Market: Global Market Size, Forecast, Insights, Segmentation, and Competitive Landscape with Impact of COVID-19 & Russia-Ukraine War
... report on global pharmacovigilance market report provides holistic understanding of the market along with market sizing, forecast, drivers, challenges, and competitive landscape. The report presents a clear picture of the global pharmacovigilance market by segmenting ... Read More
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Global Pharmaceutical Contract Manufacturing Market 2024-2028
... period. The report on the pharmaceutical contract manufacturing market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors. The report offers an ... Read More
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Global Pharmacovigilance and Drug Safety Software Market 2024-2028
... The report on the pharmacovigilance and drug safety software market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors. The report offers ... Read More
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Pharmaceutical Filtration: Global Markets
... depth filtration, cross-flow filtration), category (liquid and gas filtration, air filtration), technology (ultrafiltration, microfiltration, nanofiltration, others), and application (drug manufacturing, purification, quality control). By region, the market is categorized into North America, Europe, Asia-Pacific, and ... Read More
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Plunkett's Biotech, Pharmaceuticals & Genetics Industry Almanac 2025: Biotech, Pharmaceuticals & Genetics Industry Market Research, Statistics, Trends and Leading Companies
... vital insights that can help shape strategy for business development, product development and investments. Key Features: Business trends analysis In-depth industry overview Technology trends analysis Forecasts Spending, investment, and consumption discussions In-depth industry statistics and ... Read More
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2024 Global: Regulatory Affairs Outsourcing 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: Regulatory Affairs Market - Innovative Markets Forecast (2030) report
... 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 using regression ... Read More
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Regulatory Affairs Outsourcing Market Report by Services (Regulatory Consulting, Legal Representation, Regulatory Writing and Publishing, Product Registration and Clinical Trial Applications, and Others), Company Size (Small, Medium, Large), Category (Generic Drugs, Innovator Drugs, Biologic Drugs, Biosimilars, Medical Devices, and Others), Indication (Oncology, Neurology, Cardiology, Immunology, and Others), Stage (Preclinical, Clinical, PMA (Post Market Authorization)), End User (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies), and Region 2024-2032
... Biosimilars, Medical Devices, and Others), Indication (Oncology, Neurology, Cardiology, Immunology, and Others), Stage (Preclinical, Clinical, PMA (Post Market Authorization)), End User (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies), and Region 2024-2032 The global regulatory affairs ... Read More
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Pharmacovigilance and Drug Safety Software
... is expected to reach US$321.1 Million by 2030, growing at a CAGR of 5.8% over the analysis period 2023-2030. ADR Reporting Functionality, one of the segments analyzed in the report, is expected to record a ... Read More
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2024 Global Forecast for Regulatory Affairs Outsourcing Market (2025-2030 Outlook)-High Tech & Emerging Markets Report
... 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 billion ... Read More
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2024 Global Forecast for Regulatory Affairs 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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Pharmaceutical Inspection Machines Market Size, Share & Trends by Component ((Vision Inspection, X-Ray, Checkweigher, Metal Detector), Software), Type (Manual, Automatic), Packaging Type (Syringe, Blister, Bottle), Formulation (Parenteral, Oral) - Global Forecast to 2029
... inspection machines market is projected to reach USD 1.4 billion by 2029 from USD 0.9 billion in 2024, at a CAGR of 7.6% during the forecast period. “The Vision Inspection System segment holds dominant share ... Read More
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Cancer Treatment Drugs Markets in China
... 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 China's ... Read More
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Pharmaceutical Contract Manufacturing
... by 2030, growing at a CAGR of 5.2% over the analysis period 2023-2030. API/Bulk Drugs, one of the segments analyzed in the report, is expected to record a 4.9% CAGR and reach US$94.8 Billion by ... Read More
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Cannabis Production in Canada - Industry Market Research Report
... Canada opened up medicinal cannabis production to more players in 2013, producers have grown continuously as they invest in production capabilities to produce quality products. As consumers shifted from illegal cannabis purchases to the licensed ... Read More
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