FDA (Food and Drug Administration)

Who decides which medicines reach patients in the United States?

In one sentence

The FDA is the United States federal agency that approves medicines and watches their safety once they are on the market.

It sits inside the United States (US) Department of Health and Human Services and does the reviewing, the approving and the inspecting itself, with no second body to sign off. Its drug center runs the country’s adverse event database.

Where it sits

DepartmentHealth and Human Services (HHS)
Federal agencyFood and Drug Administration
CenterCenter for Drug Evaluation and Research (CDER)
Safety officeOffice of Surveillance and Epidemiology (OSE)Pharmacovigilance lives here

Think of it like this

Picture a harbour where customs and the lifeguard are one service. Nothing comes ashore unchecked, and somebody keeps watching the water long after the ship has docked.

Key insights

Built by two disastersIt reviews and it decides15 days, related or notSeven databases became one

A poisonous cough syrup in 1937 gave the United States its safety law; thalidomide in 1962 gave it the rule that a medicine must be proven to work. Chapter 1 tells both in three clicks.

When the FDA finds no ground for refusal, it approves the application itself. In the European Union (EU) the European Medicines Agency (EMA) gives an opinion and the European Commission takes the decision.

A company must send every serious and unexpected adverse drug experience within 15 calendar days, and the rules count an experience whether or not it is considered drug related. Chapter 2 sets the clock for you.

On 11 March 2026 the agency switched on the Adverse Event Monitoring System (AEMS) and started folding seven report databases into one.

Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with Europe 4 Test yourself

Chapter 1

Which three moments made the FDA what it is?

Pick a year. Each one left a rule that still shapes the forms you file today.

1938Safety before selling1962Proof that it works2026One database

Safety before selling

In 1937 Elixir of Sulfanilamide, a liquid antibiotic made with the poisonous solvent diethylene glycol, killed 107 people, many of them children. Nothing in the law of the day required a new drug to be tested before it was sold.

Congress answered within the year. The Federal Food, Drug, and Cosmetic Act of 1938 required new drugs to be shown safe before marketing, and it is still the core law the agency enforces.

What it left behind: every application you file begins with safety data because of a cough syrup.

Proof that it works

In 1962 thalidomide, a new sleeping pill, was found to have caused birth defects in thousands of babies in Western Europe. In the United States it had never been approved: an FDA medical officer, Frances Kelsey, had kept asking for evidence.

Public support for stronger rules led to the Kefauver-Harris amendments. For the first time, manufacturers had to prove to the agency that a drug was effective, not only safe, before marketing it.

What it left behind: the efficacy half of every review, and the habit of saying no until the data arrive.

One database

Until March 2026 the agency handled about 6 million adverse event reports a year across seven separate databases, costing about $37 million a year to run and leaving blind spots between product types.

On 11 March 2026 it launched the Adverse Event Monitoring System (AEMS). The drug and vaccine databases folded in first, the device database was to follow in May, and reports now appear in real time rather than quarterly.

What it left behind: one place to look, and since 1 October 2026 one format, E2B(R3), for every case a company sends in.

Chapter 2

Your report, their clock

A case has reached your company. Two questions in Title 21 of the Code of Federal Regulations (CFR) decide the deadline: is it serious, and is it already in the label? Pick a cell.

ExpectedUnexpectedSeriousSerious, in the labelSerious, not in the labelNot seriousNot serious, in the labelNot serious, not in the label

Or the case came another way: read in a journal article or seen in a clinical trial, fatal and unexpected

A 15-day Alert report, counted from first receipt, whether or not you think the drug caused it. Follow-up within 15 days of new information. 21 CFR 314.80(c)(1)

No alert report. All three go into the periodic report: quarterly for three years after approval, within 30 days of the quarter’s close, then yearly. 21 CFR 314.80(c)(2)

A 15-day Alert report with a copy of the article. Serious, unexpected cases in scientific or medical journals count, as case reports or trial results. 21 CFR 314.80(d)

An Investigational New Drug (IND) safety report to the review division and every investigator within 7 calendar days; other qualifying trial cases within 15. 21 CFR 312.32(c)

Any adverse event associated with the use of a drug in humans, whether or not considered drug related.
How 21 CFR 314.80(a) defines an adverse drug experience

Patients and doctors have no clock at all: they report through MedWatch, and a suspicion is enough. In March 2026 a Warning Letter to Novo Nordisk Inc. showed what forgetting the quoted words costs: its procedure let staff reject serious, unexpected cases the reporter called unrelated, so those cases were late 15-day reports.

Chapter 3

Side by side with Europe

For a European reader the European Medicines Agency (EMA) of the European Union (EU) is the natural comparison. The work is split very differently.

	United States	European Union
Who signs the approval	The FDA itself, once no ground for refusal applies	The European Commission, on the EMA’s opinion
Where company reports go	AEMS, run by the FDA	EudraVigilance, run by the EMA with the Member States
Who inspects you	FDA investigators	Your national competent authority, with the EMA
What you must have	Written procedures for surveillance, receipt, evaluation and reporting	A qualified person for pharmacovigilance, permanently and continuously, and a system master file
Is a risk plan always required	No: a Risk Evaluation and Mitigation Strategy (REMS) only when benefits would not otherwise outweigh risks	Yes: a risk management plan with every application

Show the legal references

Approval: 21 U.S.C. 355(c)(1); Regulation (EC) No 726/2004, Articles 3(1) and 10(1).
Databases: FDA press release of 11 March 2026; Regulation 726/2004, Article 24(1).
Inspections: the Bioresearch Monitoring Program named in the Warning Letter of 5 March 2026; Directive 2001/83/EC, Article 111(1).
Company obligations: 21 CFR 314.80(b); Directive 2001/83/EC, Article 104(3)(a) and (b).
Risk plans: 21 U.S.C. 355-1(a); Directive 2001/83/EC, Article 8(3)(iaa).

One body or many: in the US one agency reviews, approves, keeps the database and inspects. In the EU that work is shared between the EMA, the Commission and the national authorities.

The facts, in one place

What it is	A federal regulatory agency inside the Department of Health and Human Services, established by Title 21 of the United States Code, section 393.
Since	The Food and Drugs Act of 1906; the name Food and Drug Administration since 1930.
Head	The Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.
Seat	Silver Spring, Maryland.
Money and people	About $7 billion in fiscal year 2025, half of it from industry user fees, and 20,593 full-time equivalent posts.
Safety office	CDER’s Office of Surveillance and Epidemiology, which evaluates more than 2 million adverse event and medication error reports a year.
Member of	The International Council for Harmonisation (ICH), a founding member; the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 2011; the International Coalition of Medicines Regulatory Authorities (ICMRA).

Don’t confuse it with: CDER

FDA

The agency

Scope: drugs, biologics, devices, food, cosmetics and tobacco
Led by: the Commissioner, reporting to the Secretary of Health and Human Services
Example: a Warning Letter goes out under the agency’s name

CDER

One center inside the agency

Scope: prescription and over-the-counter drugs, biological therapeutics and generics; even sunscreen counts as a drug
Houses: the Office of Surveillance and Epidemiology, the drug safety office
Example: a trial safety report goes to the review division in CDER, or in the biologics center for a biologic

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“MedWatch is the FDA’s adverse event database.”

MythTruth

MythYou got it.Not quite.

MedWatch is the reporting programme and its forms. The database is the Adverse Event Monitoring System, which replaced the FDA Adverse Event Reporting System (FAERS) in March 2026.

“A US company must report a serious, unexpected case even when the reporter says the drug did not cause it.”