Food and Drug Administration
The U.S. Food and Drug Administration is a federal regulatory agency within HHS that protects public health by approving and overseeing the safety of food, drugs, medical devices, biologics, cosmetics, radiation-emitting products, and tobacco, employing more than 18,000 staff and regulating products representing about 20% of U.S. consumer spending.
- Company typePrivate
- Founded1906
- HeadquartersSilver Spring, United States
- Headcount5,001–10,000
- GTM typeB2B
- OfferingServices
What Food and Drug Administration does
The Food and Drug Administration is a U.S. federal regulatory agency within the Department of Health and Human Services, established under the 1906 Pure Food and Drugs Act and restructured under the 1930 Federal Food, Drug, and Cosmetic Act. Headquartered at the White Oak Campus in Silver Spring, Maryland, the FDA regulates food, human and veterinary drugs, biologics, medical devices, cosmetics, radiation-emitting products, and tobacco products — categories representing approximately 20 cents of every dollar spent by U.S. consumers. The agency employs more than 18,000 staff across all 50 U.S. states and international offices, organized into centers including CDER (drugs), CBER (biologics), CDRH (devices), CTP (tobacco), CVM (veterinary medicine), and the Human Foods Program.
The FDA's operating model combines congressional appropriations with industry user fee programs (PDUFA, MDUFA, GDUFA, BsUFA) to fund product reviews. The agency does not sell products commercially; instead, it provides regulatory services, guidance documents, advisory committee input, and public access to databases such as Drugs@FDA, the Orange Book, and the 510(k) database. Recent technical investments include the Elsa 4.0 generative AI tool and the HALO data platform, which consolidates more than 40 internal data sources on a FedRAMP High Google Cloud environment. The agency has executed a 19% workforce reduction, launched the FDA PreCheck Pilot Program, broken ground on a $228 million food safety laboratory in Denver, and entered a reciprocal liaison programme with the UK MHRA, while operating under an acting commissioner following Commissioner Marty Makary's May 2026 resignation.
Food and Drug Administration firmographics
Firmographics- Name
- Food and Drug Administration
- Legal name
- Food and Drug Administration
- Website
- https://fda.gov
- Company type
- Private
- Founded year
- 1906
- Operating status
- Operating
- Headcount range
- 5,001–10,000 employees
- Short description
- The U.S. Food and Drug Administration is a federal regulatory agency within HHS that protects public health by approving and overseeing the safety of food, drugs, medical devices, biologics, cosmetics, radiation-emitting products, and tobacco, employing more than 18,000 staff and regulating products representing about 20% of U.S. consumer spending.
- Ownership category
- akta.pro rank
Food and Drug Administration industry classification
Industry- Product category
- Federal Pharmaceutical and Medical Device Regulation
- NAICS
- Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (926150), Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615)
- SIC
- Services-Medical Laboratories (8071)
- akta.pro primary industry
- Drug Regulators (Human Pharmaceuticals) (HLAJADAA)
- akta.pro secondary industries
- Food Standards, Labeling & Claims Regulation (HLAJAEAB), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI), Food Testing, Laboratory Oversight & Method Standards (HLAJAEAF), Controlled Substances & Pharmacy Regulation Authorities (HLAJACAI)
Keywords
Where Food and Drug Administration is headquartered
LocationHeadquarters
- HQ city
- Silver Spring
- HQ country
- United States
- HQ region
- North America
Offices4 records
Markets served
Food and Drug Administration business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Others
Revenue model
- Federal Appropriations: The FDA is a part of the Department of Health and Human Services and is funded through federal appropriations. User fee programs support review of innovator drugs, medical devices, generic drugs, and biosimilar products.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | User fee programs for regulated industries |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
Food and Drug Administration product offering
Product offeringCore offering
The U.S. Food and Drug Administration (FDA) is a federal regulatory agency within the U.S. Department of Health and Human Services that protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biologics, medical devices, food, cosmetics, and radiation-emitting products, and by regulating tobacco products. The agency conducts scientific reviews for product approvals, sets regulatory standards, issues guidance documents, and performs compliance inspections and enforcement actions.
Differentiator
Problem solved
Functional benefit
Brands
- CDER (Center for Drug Evaluation and Research): FDA center responsible for ensuring safe and effective drugs are available to improve the health of the people in the United States
- CBER (Center for Biologics Evaluation and Research)
- CDRH (Center for Devices and Radiological Health)
- CTP (Center for Tobacco Products)
- CVM (Center for Veterinary Medicine)
Products and services
- FDA PreCheck Pilot Program A pilot regulatory program designed to help pharmaceutical manufacturers establish new U.S. drug manufacturing facilities by streamlining FDA engagement during site design and construction. The program is for pharmaceutical manufacturers seeking to build or expand domestic production capacity.
- Commissioner's National Priority Voucher (CNPV) Pilot Program A pilot initiative using a tumor board-style collaborative review process to accelerate FDA review of drug and biological product applications identified as national priorities. It is aimed at sponsors of innovative or high-priority drug and biologic candidates.
- Expedited-IND Acceleration Pilot (Operation Trailblazer) A pilot under HHS's Operation Trailblazer designed to accelerate investigational new drug (IND) review timelines and modernize U.S. clinical trial infrastructure, including potential single-IRB rulemaking for multi-site trials. It is targeted at clinical trial sponsors and investigators.
- FDA Public Regulatory Databases (Drugs@FDA, Orange Book, 510(k), NDC Directory, Recalls, Warning Letters) Public-facing regulatory databases published on FDA.gov providing searchable access to drug approvals, generic drug equivalents, medical device clearances, National Drug Code listings, recall records, and warning letters. They are used by healthcare professionals, regulated industry, researchers, and the general public.
- FDA Newsroom, Press Announcements, and Email Alert Subscriptions
- FDA Contact Center (1-888-INFO-FDA) and Specialized Information Lines
Quantifiable outcome
- More than 18,000 employees working in all 50 states and internationally to protect public health
- +1 more outcomes
Companies that use Food and Drug Administration
Customer profileNamed customers3 records
Segments4 records
Ideal customer profiles3 records
Food and Drug Administration technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Food and Drug Administration partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- UK Medicines and Healthcare products Regulatory Agency (MHRA)coreThe FDA and MHRA announced a new reciprocal liaison programme establishing dedicated liaison officer roles within each organization to deepen regulatory cooperation. The initiative aims to accelerate alignment on innovative medicines, medical devices, and emerging technologies like AI while maintaining full regulatory independence for both agencies. Industry groups including the ABHI, AdvaMed, and BritishAmerican Business welcomed the partnership.
- International Regulatory PartnerscoreFDA's Office of Global Policy and Strategy coordinates international arrangements including Memoranda of Understanding and Confidentiality Commitments with foreign regulatory counterparts. The agency has regional offices in China, Europe, India, and Latin America to support international regulatory cooperation.
- Department of Health and Human Services (HHS)coreOperation Trialblazer is a department-wide initiative launched by HHS and Secretary Robert F. Kennedy, Jr. to modernize U.S. clinical trials and reverse the offshoring of biomedical research. The initiative includes FDA's Expedited-IND Acceleration Pilot and potential rulemaking for single Institutional Review Board for multi-site trials.
Scale indicators5 records
Recent moves6 records
Expansion highlights4 records
Food and Drug Administration competitors and assessment
Company assessmentBroad incumbents
- European Medicines Agency (EMA): The EU's central medicines regulator, evaluating and supervising human and veterinary medicines across all EU member states. Directly comparable to FDA's CDER/CBER/CVM centers in scope (drugs, biologics, veterinary) and offers the closest international benchmark for FDA review pathways and approval timelines.
- Pharmaceuticals and Medical Devices Agency (PMDA, Japan): Japan's national regulator for pharmaceuticals and medical devices. Comparable in mandate (drugs, biologics, devices), with similar scientific review depth; relevant peer for benchmarking FDA's user-fee-funded review model and Asian market pathway convergence.
- National Medical Products Administration (NMPA, China): China's regulator for drugs, medical devices, cosmetics, and food. Increasingly relevant peer given FDA's China regional office and the global convergence/competition dynamic for first-launch decisions in major therapeutic categories.
- Centers for Disease Control and Prevention (CDC): Sister HHS agency responsible for public health surveillance, emergency preparedness, and infectious disease response. Comparable as a large U.S. federal public health authority that the FDA coordinates with on vaccine review, EUA decisions, and outbreak response.
Direct peers
- UK Medicines and Healthcare products Regulatory Agency (MHRA): The UK's regulator for medicines, medical devices, and blood components. The FDA's newly announced reciprocal liaison programme with MHRA makes it the most functionally aligned peer, both in terms of products regulated and the current strategic emphasis on AI and innovative medicine alignment.
- Health Canada - Health Products and Food Branch: Canada's federal regulator overseeing drugs, medical devices, biologics, and food safety. Functionally equivalent across nearly all of FDA's product categories and now a counterparty for the Colorado drug importation program, making it a close operational peer.
- Therapeutic Goods Administration (TGA, Australia): Australia's regulator for therapeutic goods including prescription medicines, OTC, medical devices, and biologics. Comparable to FDA in product coverage and is a Project Orbis and comparable overseas regulator pathway partner used to accelerate U.S. oncology and rare disease approvals.
- European Food Safety Authority (EFSA): The EU's food safety risk assessment body, paralleling the FDA's Human Foods Program and food safety laboratory functions. Directly comparable in food standards, labeling oversight, contaminant testing, and chemical safety reassessment work.
Regional players
- Brazilian Health Regulatory Agency (ANVISA): Brazil's health regulator covering drugs, biologics, devices, food, cosmetics, and tobacco - closely mirroring FDA's portfolio. Relevant regional peer given FDA's Latin America regional office and harmonization agenda.
Others
- National Institutes of Health (NIH): U.S. federal agency funding biomedical research and the developer of many therapies FDA later reviews. Adjacent peer within HHS that shapes FDA's upstream pipeline; the FDA-NIH dynamic directly influences review volume, breakthrough designations, and translational science policy.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
Food and Drug Administration social profiles
Digital presenceFood and Drug Administration financial estimates
Financial estimateRevenue estimate
Valuation estimate
Food and Drug Administration leadership team
Management profileNumber of profiles
Profiles4 records
Food and Drug Administration funding detail
Funding detailFunding overview
Funding rounds
Investors
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Food and Drug Administration M&A and investment
M&A and investmentM&A
Investments1 record
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Food and Drug Administration
What does Food and Drug Administration do?
The U.S. Food and Drug Administration (FDA) is a federal regulatory agency within the U.S. Department of Health and Human Services that protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biologics, medical devices, food, cosmetics, and radiation-emitting products, and by regulating tobacco products. The agency conducts scientific reviews for product approvals, sets regulatory standards, issues guidance documents, and performs compliance inspections and enforcement actions.
Is Food and Drug Administration a public or private company?
Food and Drug Administration is a private company. It is classified as state government owned and is currently operating.
When was Food and Drug Administration founded?
Food and Drug Administration was founded in 1906. It employs 5,001 to 10,000 people.
Where is Food and Drug Administration based?
Food and Drug Administration is headquartered in Silver Spring, United States, in the North America region.
How does Food and Drug Administration make money?
One revenue line is on record: federal Appropriations.
Who are Food and Drug Administration's main competitors?
Broad incumbents on record are European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA, Japan), National Medical Products Administration (NMPA, China) and Centers for Disease Control and Prevention (CDC). Direct peers are UK Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada - Health Products and Food Branch, Therapeutic Goods Administration (TGA, Australia) and European Food Safety Authority (EFSA). Brazilian Health Regulatory Agency (ANVISA) is listed as a regional player. National Institutes of Health (NIH) is listed as an others.
Does Food and Drug Administration have an API?
No public API is recorded for Food and Drug Administration.
What industry is Food and Drug Administration in?
Food and Drug Administration's product category is Federal Pharmaceutical and Medical Device Regulation. Its primary akta.pro industry code is HLAJADAA, Drug Regulators (Human Pharmaceuticals), with a secondary code of HLAJAEAB, Food Standards, Labeling & Claims Regulation. Its NAICS code is 926150 and its SIC code is 8071.