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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 Approves Venclexta for Certain Types of Leukemia and Lymphoma

Study found Venclexta plus Gazyva (obinutuzumab) delayed disease progression in previously untreated patients.

FDA Approves Tibsovo As First-Line Treatment for AML With IDH1 Mutation

More than 40% of patients with acute myeloid leukemia achieved complete remission.

FDA’s New Efforts to Help Ensure Safety of Breast Implants

The FDA does not believe that, on the basis of all available information, textured implants meets the banning standard.

Mammography: What You Need to Know

The FDA is proposing updates to mammography regulations to reflect advances in technology and processes. How could these changes affect you?

FDA Encourages More Participation, Diversity in Clinical Trials

Overall, few people actually sign up for and participate in trials, and those who do participate don’t always represent the U.S. population.

Fact or Fiction: What to Know About Smoking Cessation and Medications

The FDA wants to help separate fact from fiction to when it comes to methods used to quit smoking.

FDA Aims to Modernize and Improve Quality of Mammography Services

Proposed rule would require breast density reporting and enhance the FDA’s ability to enforce compliance.

FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung Cancer

Progression-free and overall survival improved in patients treated with Tecentriq plus chemotherapy.

New Strategies to Modernize Clinical Trials to Advance Precision Medicine

We look forward to working with our many stakeholders to make the promise of precision medicine a reality for more people.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

FDA Approves Atezolizumab for PD-L1 Positive Triple-Negative Breast Cancer

Tecentriq plus Abraxane was approved under accelerated approval based on progression-free survival.

FDA’s Youth Tobacco Prevention Plan: Fighting Youth Access to E-Cigarettes

The agency announces “forceful” new actions focused on retailers and manufacturers.

FDA Approves New Formulation of Herceptin for Subcutaneous Use

HannaH trial demonstrated that Herceptin Hylecta was comparable to intravenous trastuzumab.

breast cancer, breast reconstruction, breast implants, UC San Francisco, Hani Sbitany, plastic surgery

FDA Warns Against Using Robotic Surgery to Treat Cancer

Agency wants doctors and patients to be aware of the lack of evidence of safety and effectiveness so they can make informed decisions.

FDA Warns Not to Use Thermography Devices to Detect Breast Cancer

FDA Approves Lonsurf for Recurrent, Metastatic Gastric Cancer

Median overall survival was 5.7 months for patients receiving Lonsurf and 3.6 months for those receiving placebo.

Clearing a Path for More Efficient Generic Drug Development

Branded drugs with expired patents but without generic competition may keep prices high and ultimately hurt patients.

Supporting Novel Nicotine Replacement Therapies to Help Smokers Quit

The draft guidance will outline ways to develop and label smoking-cessation aids to reduce the risk of relapse.

FDA Advances New Rule to Ensure Sunscreens Are Safe and Effective

The proposal addresses active ingredient safety, dosage forms, and SPF and broad-spectrum requirements for over-the-counter sunscreens.


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