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Overview

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Articles

FDA Responds to New Data Showing More Youth Use Tobacco Products

The epidemic-level rises in youth e-cigarette use is threatening the progress we’ve made toward reducing youth tobacco use.

FDA Continues Education About Risk of Lymphoma From Breast Implants

Global reports show nearly 250 new cases of non-Hodgkin lymphoma in women with breast implants.

Advancing Complex Generics to Improve Patient Access to Medicines

This focus is critical because, first and foremost, these drug products provide people with important therapies.

FDA Finalizes Policy on Labeling for Drugs Approved Under Accelerated Approval

The accelerated approval pathway facilitates earlier approval of drugs that treat serious conditions.

New FDA Policies on Developing Safe, Effective Cell and Gene Therapies

The accelerated approval pathway may offer a faster route to approval for new treatments in significant, unmet medical needs.

FDA Approves Longer-Acting Chemotherapy for Leukemia

Asparlas approved for children and young adults with acute lymphoblastic leukemia.

FDA Approves First Treatment for Rare Blood Cancer

Elzonris approved for bone marrow disease that can evolve into leukemia.

FDA Regulation of Products Containing Cannabis

Farm bill decriminalizes hemp, FDA still regulates products containing cannabis and compounds like cannabidiol.

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Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

FIT test, colon cancer screening

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

Keytruda, pembrolizumab

FDA Approves Keytruda For Merkel Cell Carcinoma

Pembrolizumab led to 56 percent overall response rate for rare skin cancer.

FDA Approves Lynparza for Ovarian Cancer Maintenance Therapy

PARP inhibitor slowed disease progression in clinical study.

New Safety and Efficacy Information on Generic Cancer Drugs Labels

The FDA wants to give prescribers and patients access to the most up-to-date information to guide treatment decisions.

FDA to ‘usher in a new era of competition for biosimilars’

“The result of this progress is that we openly talk about curing cancers that were recently fatal,” says Commissioner Gottlieb.

Tecentriq (atezolizumab)

FDA Approves Atezolizumab With Chemotherapy and Bevacizumab for Metastatic Non-Small-Cell Lung Cancer

Tecentriq plus chemotherapy and Avastin delays disease progression and death.

FDA Encourages Use of Real-World Evidence to Support New Drugs

The agency hopes to make better use of information from patients and providers.

New Guidelines for Developing and Labeling Diagnostics for Cancer Drugs

Where appropriate, the FDA supports broader labeling of companion diagnostics.

FDA’s New Action to Advance the Development of Reliable Genetic Tests

The agency clarifies how test developers may use clinical evidence in public databases to show that their test is “clinically valid.”