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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Orphan Drugs: New thinking on RWE generation and value
... in the successful development and launch of an orphan drug. But how can pharma generate persuasive RWE that supports their proposition and meets stakeholders needs? Why are patient-reported outcomes growing in importance? How can AI ... Read More
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Efficacy Testing Market by Service Type (Antimicrobial/Preservative Efficacy Testing, Disinfectant Efficacy Testing), Application (Pharma, Cosmetics & Personal Care, Medical Devices, Consumer Products) and Region - Global Forecast to 2027
... projected to reach USD 423 million by 2027 from USD 315 million in 2022, at a CAGR of 6.1% during the forecast period. The growth of this market is mainly driven by the increasing use ... Read More
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Pharmacovigilance Market Intelligence Report - Global Forecast to 2027
... period. Market Statistics: The report provides market sizing and forecast across 7 major currencies - USD, EUR, JPY, GBP, AUD, CAD, and CHF. It helps organization leaders make better decisions when currency exchange data is ... Read More
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Pharmacovigilance & Drug Safety Software Market Intelligence Report - Global Forecast to 2027
... 2021, at a CAGR 14.07% during the forecast period. Market Statistics: The report provides market sizing and forecast across 7 major currencies - USD, EUR, JPY, GBP, AUD, CAD, and CHF. It helps organization leaders ... Read More
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Orphan Drugs: Pharma/DTC genetic testing partnerships
... can inform clinical development programs. Partnership with genetic testing companies is key, but what are the pros, cons and dangers of operating in this unregulated space? In this report, experts in the field examine the ... Read More
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The Rise of Patient Support Programs: Opportunities for Pharma
... you build awareness of your PSP? In what ways is digital technology driving PSP innovation and outcomes? What are the downsides of PSP generated pharmacovigilance data? How can PSPs play into your go-to-market strategy? In ... Read More
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Life Science Analytics Market: Market Segments: By Type (Reporting, Descriptive, Predictive and Prescriptive); By Application (Research and Development, Sales and Marketing, Regulatory Compliance, Supply Chain Analytics and Pharmacovigilance); By Delivery Model (On-demand and On-premises); By End-user (Medical Devices, Pharmaceutical, Biotechnology and Others); and Region – Global Analysis by Market Size, Share & Trends for 2014 – 2020 and Forecasts to 2030
... End-user (Medical Devices, Pharmaceutical, Biotechnology and Others); and Region – Global Analysis by Market Size, Share & Trends for 2014 – 2020 and Forecasts to 2030 Product Overview Pharmaceutical and life science businesses primarily use ... Read More
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Asia Pacific Pharmacy Automation Market by Product (Automated Medication Dispensing & Storage Systems, Automated Table-Top Counters, Medication Compounding), End User (Inpatient Pharmacies, Outpatient Pharmacies, Retail Pharmacies) - Forecast to 2027
... market is expected to grow at a CAGR of 9.8% in the forecast period. The Asia Pacific pharmacy automation market is projected to reach USD 725 million by 2027 from USD 453 million in 2022, ... Read More
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2022 Testing Services for Pharmaceutical, Medical Devices, and Personal Care Products Global Market Size & Growth Report with COVID-19 Impact
... Size & Growth Report covers market size, revenue, growth, and share across 4 global regions, 22 subregions, and 216 countries. Figures are from 2012 through 2021, with forecasts for 2022 and 2026. The historical data ... Read More
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Regulatory Affairs Outsourcing Market - Global Outlook and Forecast 2022-2027
... market growth during the forecast period: Increasing Use of Digital Platforms/Solutions in Regulatory Affairs Changing Regulatory Landscape Rising Demand For Fast Drug & Medical Device Approvals Impact of Strict Government Regulations REGULATORY AFFAIRS OUTSOURCING MARKET ... Read More
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Analytical Standards Global Market Opportunities And Strategies To 2030: COVID-19 Growth And Change
... and senior management with the critical information they need to assess the global analytical standards market as it emerges from the COVID 19 shut down. Reasons to Purchase Gain a truly global perspective with the ... Read More
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Pharmaceutical Filtration Market Size, Share & Trends Analysis By Product, By Systems, By Technique, By Application, By Scale of Operation, Regional Outlook, Competitive Strategies and Segment Forecasts to 2030
... to be worth USD 36.13 billion by 2030. According to SPER Market Research, the Pharmaceutical Filtration Market is estimated to reach USD 36.13 billion by 2030 with a CAGR of 15.6%. The increasing adoption of ... Read More
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Pharmacovigilance And Drug Safety Software Market Size, Share & Trends Analysis Report By Functionality, By Delivery Mode (On Premise, On Demand), By End-use, By Region, And Segment Forecasts, 2022 - 2030
... Research, Inc. The market is expected to expand at a lucrative CAGR of 10.5% from 2022 to 2030. The key factors driving the market growth include increasing need to track and manage adverse drug reactions ... Read More
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United States Human Vaccines Market Size, Share, Top 45 Human Vaccines Brand In-depth Analysis, Emerging Trends, Current Analysis, Growth, Demand, Opportunity, and Forecast 2022 – 2028
... market is poised to grow by US$ 31,517 million by 2028, accelerating at a CAGR of 7% during the forecast period. The prominent factors that are expected to contribute to the growth of the United ... Read More
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Global Pharmacovigilance Market - 2022-2029
... with the detection, understanding, assessment, and prevention of adverse effects or any other drug-related problem. The focus of pharmacovigilance is on ADR (adverse drug reactions) and drug toxicity. The pharmacovigilance market comprises all types of ... Read More
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Metal Detector Market: Trends, Opportunities and Competitive Analysis
... textile industries. The metal detector market is expected to reach an estimated $2 billion by 2027 and is forecast to grow at a CAGR of 3.9% from 2021 to 2027. The major drivers for this ... Read More
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Pharmacy Benefit Management Market in the US - Industry Outlook & Forecast 2022-2027
... a detailed overview of several industry growth enablers, restraints, and trends. The report offers both the demand and supply aspects of the market. It profiles and examines leading companies and other prominent ones operating in ... Read More
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Pharmacovigilance Market, By Type of Clinical Trial Phases (Pre-clinical Studies, Clinical Trial Phase I, Clinical Trial Phase II, Clinical Trial Phase III, Post Marketing Surveillance or Phase IV), By Type of Method (Spontaneous Reporting, Intensified AD
... ADR Reporting, Targeted Reporting, Cohort Event Monitoring, EHR Monitoring), By Type of Service Providers (In-House, Contract Outsourcing), By Region (North America, Latin America, Europe, Asia Pacific, Middle East & Africa) - Size, Share, Outlook, and ... Read More
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The Market for Rx-to-OTC Switches, 8th Edition
... market. This has mainly been due to factors such as patent expirations, increasing competitiveness with the pharmaceutical environment, the FDA willingness to work with industry, brand re-invention, consumer demand, and cost containment strategies. The U.S. ... Read More
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Pharmaceutical Analytical Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
... 11,387.35 million by 2027, registering a CAGR of 8.20% from 2022 to 2027. While the sudden outbreak of the COVID-19 pandemic has negatively impacted most business sectors, the pharmaceutical analytical testing market has shown consistent ... Read More
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IDC Perspective: Real-World Evidence and Drug Pricing in 2022
... patients, private and government healthcare payers, life science companies, and society at large. "As life science companies, private and public healthcare payers, and healthcare providers learn to use RWE to discover the true value of ... Read More
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Testing, Inspection, and Certification Market with Covid-19 Impact Analysis by Service Type (Testing, Inspection, and Certification), Sourcing Type (In-house, Outsourced), Application and Geography - Global Forecast to 2027
... projected to reach USD 268.9 billion by 2027 from USD 221.4 billion in 2022; it is expected to grow at a CAGR of 4.0% from 2022 to 2027. The growth of the Testing, inspection, and ... Read More
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Turkey - Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape
... Reimbursement and Competitive Landscape”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Turkey. It identifies the key trends in the country’s healthcare market and provides ... Read More
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Orphan Drugs Market by Disease Type (Oncological Diseases, Metabolic Diseases, Hematologic & Immunologic Diseases, Infectious Diseases, Neurologic Diseases, and Other Rare Diseases): Global Opportunity Analysis and Industry Forecast, 2021–2030
... valued at $1,40,000.0 million in 2020 and is projected to reach $4,35,686.3 million by 2030 registering a CAGR of 11.8% from 2021 to 2030. The pharmaceutical agents administered to treat, diagnose, and prevent life-threatening diseases ... Read More
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Saudi Arabia - Healthcare (Pharmaceuticals and Medical Devices), Regulatory and Reimbursement Landscape
... The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Saudi Arabia. It identifies the key trends in the country’s healthcare market and provides insights into its ... Read More
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