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 Pharmaceutical & Biotechnology Environmental Monitoring Market Growth (Status and Outlook) 2023-2029
... both viable (living microorganisms) and non-viable particles (e.g. dust, hair, etc.) and other contaminants (i.e. trace metals, volatiles, etc.) for aseptic manufacturing operations are more extensive than those for non-sterile processes, the quantity of samples ... Read More
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Global Orphan Drugs Market Research Report 2022 - Market Size, Current Insights and Development Trends
... report focuses on the Orphan Drugs market size, segment size (mainly covering product type, application, and geography), competitor landscape, recent status, and development trends. Furthermore, the report provides strategies for companies to overcome threats posed ... Read More
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2023 Global Forecast for Contract Research Organization Services (Cros) Market (2024-2029 Outlook)-High Tech & Emerging Markets Report
... over 50 countries. The global market is expected to increase from USD xx billion in 2024 to USD xx billion by 2029, at a CAGR of xx% from 2024 to 2029. Estimates on equipment or ... Read More
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Real-world Data (RWD) by Source (EMR, Claims, Pharmacy, Disease Registries), Application [Market Access, Drug Development & Approvals (Oncology, Neurology), Post Market Surveillance], and End User (Pharma, Payers, Providers) - Global Forecast to 2029
... (RWD) by Source (EMR, Claims, Pharmacy, Disease Registries), Application [Market Access, Drug Development & Approvals (Oncology, Neurology), Post Market Surveillance], and End User (Pharma, Payers, Providers) - Global Forecast to 2029 The real-world data (RWD) ... Read More
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Jordan Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape
... Competitive Landscape”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Jordan. It identifies the key trends in the country’s healthcare market and provides insights into ... Read More
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China Contract Manufacturing Market Outlook - Trends, Ambitions, Key Players, Investment and Value Chain
... It assesses which foreign and domestic pharma manufacturing companies have the largest number of facilities in China, their manufacturing capabilities, which CMOs have secured the largest number of contracts for FDA and EMA approved products ... Read More
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Pharmaceutical Gelatin Market by Source (Porcine, Bovine Skin, Bovine Bone, Fish, Poultry), Application (Hard Capsule, Soft Capsule, Tablet, Absorbable Hemostat), Function (Stabilizing, Thickening, Gelling), Region - Global Forecast to 2027
... is projected to reach USD 1.5 Billion by 2027 from USD 1.1 Billion in 2022, at a CAGR of 5.5% during the forecast period of 2022-2027. Market growth can be attributed to the functional abilities ... Read More
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Global Pharmacovigilance Software Market 2022-2028
... Gen Consulting Company. The report covers market size and growth, segmentation, regional breakdowns, competitive landscape, trends and strategies for global pharmacovigilance software market. It traces the market’s historic and forecast market growth. The report identifies ... Read More
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Global Pharmacovigilance Market Size, Trends & Growth Opportunity, Product & Service, By Drug development (Phase1, Phase 2, Phase3, Phase4 or Post marketing Surveillance), By Types of Method (Spontaneous Reporting, Intensified ADR Reporting), By Types of Services (In House, Contract Outsourcing), By Region & forecast till 2027.
... Services (In House, Contract Outsourcing), By Region & forecast till 2027. Global Pharmacovigilance Market Global Pharmacovigilance Market was valued at USD 6.97 billion in 2021 and expected to reach at USD 13.80 billion by 2027 ... Read More
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Global Contract Development and Manufacturing Organization (CDMO) Outsourcing Market 2023-2027
... at a CAGR of 12.76% during the forecast period. Our report on the contract development and manufacturing organization (CDMO) outsourcing market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as ... Read More
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Pharmaceutical Quality Management Software Market Size, Share & Trends Report, 2022-2030
... the market dynamics of the industry. It provides an in-depth analysis of the market segments which include types, applications, and competitor analysis. The global Pharmaceutical Quality Management Software market size is growing at a CAGR ... Read More
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Argentina Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape
... Competitive Landscape”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Argentina. It identifies the key trends in the country’s healthcare market and provides insights into ... Read More
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GMP Testing Service Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
... were implemented following the COVID-19 outbreak in order to stop the virus's spread. Both demand-side and supply-side effects on the industrial sector have been seen as a result of these lockdowns. People are learning to ... Read More
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Pharmacovigilance Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
... is adversely affecting communities, industries, businesses, and lives around the world. Medical monitoring and safety reporting are essential as several potential therapies are being used in the treatment of coronavirus-induced infection. For instance, the article ... Read More
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Drug Manufacturing Sector Scorecard - Thematic Intelligence
... developed, manufactured, and delivered to patients. Outsourced manufacturing is a key supply chain component and is being driven by increased drug consumption and the development of more advanced treatments. Pharma is under increasing pressure to ... Read More
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Regulatory Intelligence Report for Pharmaceuticals in the U.S.
... comprehensive procedure for the registration, renewal, or notification of the pharmaceuticals, along with the information on the timeline and fee required. The report also focuses on the labeling and advertising regulations for the pharmaceutical and ... Read More
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Clinical Trials Outsourcing Market Size & Share 2022 Outlook Report With COVID-19 Updated Analysis Forecast till 2030
... that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include types, applications, and competitor analysis. The global Clinical Trials Outsourcing market size is growing at ... Read More
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Global Orphan Drugs Market - 2022-2029
... during the forecast period (2022-2029). Life-threatening or persistently disabling diseases are treated, prevented from occurring, or diagnosed with an orphan drug. It is mostly used to treat rare disorders. Less than 200,000 Americans and five ... Read More
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Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
... - 2027). The contract development and manufacturing organization outsourcing market will expand due to the expanding pharmaceutical sector. The key trend affecting the market growth for outsourcing by contract development and manufacturing organizations is the ... Read More
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Global Orphan Drugs Market Research Report 2022(Status and Outlook)
... without government assistance. The conditions are referred to as orphan diseases. The Global Orphan Drugs Market Size was estimated at USD 139170.00 million in 2021 and is projected to reach USD 269480.00 million by 2028, ... Read More
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2022 Testing Services for Pharmaceutical, Medical Devices, and Personal Care Products Global Market Size & Growth Report with Updated Forecasts
... Figures are from 2012 through 2021, with forecasts for 2022 and 2026. The historical data utilizes in-depth survey results from companies that sell testing services for pharmaceutical, medical devices, and personal care products combined with ... Read More
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Venezuela Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape
... Competitive Landscape”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Venezuela. It identifies the key trends in the country’s healthcare market and provides insights into ... Read More
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Indonesia Healthcare (Pharma and Medical Devices) Market Analysis, Regulatory, Reimbursement and Competitive Landscape
... Competitive Landscape”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Indonesia. It identifies the key trends in the country’s healthcare market and provides insights into ... Read More
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Global Authentication and Brand Protection Market: Analysis By Application (Medical, Automotive, Food and Beverage, Consumer Electronics, and Others) and By Technology (Digital and Non Digital) By Region Size And Trends With Impact of COVID-19 And Forecast up to 2027
... Forecast up to 2027 The global authentication and brand protection market in 2021 was valued at US$2.88 billion. The market is expected to reach US$4.91 billion by 2027. Authentication and Brand Protection is a business ... Read More
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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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