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
-
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
-
Real World Evidence Solutions Market by Component (Services, Disparate Data Sets (Clinical), Application (Drug and Medical Device Development and Approvals), Mode of Deployment, Revenue Model, End Users, & Region, Business Model - Global Forecast to 2029
... 2029 The global Real-World Evidence Solutions market is projected treach USD 4.5 Billion by 2029 from USD 2.0 billion in 2024, at a CAGR of 16.5% from 2024 t2029. The growth of the market is ... Read More
-
Australia and New Zealand Endotoxin Testing Market Report and Forecast 2024-2032
... endotoxin testing market size is anticipated to grow at a CAGR of 9.5% during the forecast period of 2024-2032, driven by the increase in development of innovative, rapid, and sensitive testing methods. Endotoxin Testing: Introduction ... Read More
-
Pharmaceuticals Markets in China
... 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, investment environment, ... Read More
-
GMP Testing Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)
... 2 billion by 2029, growing at a CAGR of 6.84% during the forecast period (2024-2029). Lockdowns were implemented following the COVID-19 outbreak to stop the virus's spread. Both demand and supply-side effects on the industrial ... Read More
-
Cloud Computing in Healthcare Market by Product (Healthcare Payer Solutions, Healthcare Provider Solutions), Component (Services, Software), Pricing Model, SERVICE MODEL, Deployment Model - Global Forecast 2024-2030
... at USD 49.40 billion in 2023 and expected to reach USD 58.93 billion in 2024, at a CAGR 19.39% to reach USD 170.82 billion by 2030. FPNV Positioning Matrix The FPNV Positioning Matrix is pivotal ... Read More
Research Assistance
