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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
The 2025-2030 World Outlook for Pharmacovigilance Technologies
... 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 gauge a ... Read More
-
The 2025-2030 World Outlook for Orphan Drugs
... 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 gauge a ... Read More
-
The 2025-2030 World Outlook for GxP-GMP Regulation Testing Services
... 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
-
The 2025-2030 World Outlook for Post-Marketing Pharmacovigilance and Medical Information
... 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
-
The 2025-2030 World Outlook for Validation, Calibration and Standardization in the Global Life Sciences
... For each year reported, estimates are given for 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, ... Read More
-
The 2025-2030 World Outlook for Counterfeit Drug Detection Devices
... 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
-
Orphan Drugs Global Market Report 2024
... Distribution Channel: Hospital Pharmacy; Retail Pharmacy; Online Sales Covering: Pfizer Inc.; Johnson & Johnson Services Inc.; F Hoffmann-La Roche Ltd.; Farbenfabriken Bayer AG; Novartis AG Orphan Drugs Global Market Report 2024 from The Business Research ... Read More
-
Pharma Wholesale and Distribution Market Report 2024-2034
... industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region. Increasing Government Initiatives for Pharmaceutical Products ... Read More
-
Global Pharmaceutical Testing Market Professional Survey by Types, Applications, and Players, with Regional Growth Rate Analysis and Development Situation, from 2023 to 2028
... of the Pharmaceutical Testing industry between the year 2018 to 2028, and breaks down according to the product type, downstream application, and consumption area of Pharmaceutical Testing. The report also introduces players in the industry ... Read More
-
Pharmacovigilance Global Market Report 2024
... Management; Signal Detection; Risk Management System 4) By Clinical Trial Phases: Preclinical; Phase I; Phase II; Phase III; Phase IV 5) By End User: Hospitals; Pharmaceutical Companies Covering: IQVIA; Cognizant; ICON Plc; Accenture plc; PAREXEL ... Read More
Research Assistance
