Today, FDA issued a proposed administrative order to address a safety issue related to over-the-counter (OTC) monograph drugs containing acetaminophen. This proposed order, if finalized, would require drug companies to add a warning to the labeling: https://lnkd.in/eDXSXsPJ
About us
The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
- Website
-
http://www.fda.gov/
External link for FDA
- Industry
- Government Administration
- Company size
- 10,001+ employees
- Headquarters
- Silver Spring, MD
- Type
- Government Agency
- Specialties
- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
Locations
-
Primary
Get directions
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
-
The FDA has updated its Recognized Consensus Standards database, known as “List 62.” The update includes new standards, including one in the ASCA program. List 62 also contains new versions of recognized standards, and revision to one standard’s extent of recognition. Find out more: https://lnkd.in/e5rjGGP
-
-
On June 10, in partnership with the Clinical Data Interchange Standards Consortium (CDISC), FDA’s Center for Tobacco Products (CTP) released the Tobacco Implementation Guide – a new resource for stakeholders to use to help facilitate tobacco product research and scientific review. The resource – which includes data standards that can help optimize scientific accuracy and review efficiency - was created by a multidisciplinary team from CTP, tobacco industry stakeholders, and CDISC with public/community review. Learn more: https://lnkd.in/ddGF_TRW
-
-
Patients who rely on prescription stimulant medications to treat their ADHD and have been using a telehealth platform could experience a disruption to their treatment and disrupted access to care. Health officials and healthcare providers may need to assist affected patients seeking treatment for ADHD and should communicate overdose risks associated with the current illegal drug market. Find more information in the CDC Health Advisory.
CDC issues Health Alert Network (HAN) Health Advisory to inform public health officials, clinicians, and affected patients, their families, and caregivers about potential disrupted access to care among individuals taking prescription stimulant medications and possible increased risks for injury and overdose. Read full advisory: https://bit.ly/45mmjq0
-
-
FDA is issuing exemptions from certain requirements of section 582 of the Food, Drug and Cosmetic Act to small dispensers (pharmacies), and where applicable their trading partners, until November 27, 2026: https://lnkd.in/eyuGwzgr This provides small dispensers additional time to stabilize their operations to fully implement the enhanced drug distribution security requirements of the Drug Supply Chain Security Act (DSCSA).
-
-
📣Join FDA & the Foundation for the National Institutes of Health on June 24-25 for a hybrid public workshop to discuss the effective integration of Digital Measures into clinical trials and medical product development. Learn more and register today ➡ https://lnkd.in/eVcmAmN6
-
-
Join the Conversation! Starting now, Conversations on Cancer: 4th Annual National Black Family Cancer Awareness Week, Engaging the Generations, #BlackFamCan, with the FDA Oncology Center of Excellence and a panel of invited guests on efforts to increase cancer awareness, prevention, treatment access, and awareness of clinical trials, among vulnerable Black communities in the U.S. #CancerMoonshot https://lnkd.in/eK4rtqx2
4th Annual National Black Family Cancer Awareness, Engaging the Generations, #BlackFamCan
https://www.youtube.com/
-
In this CDER Conversation, Dr. Robert Ball, Deputy Director, Office of Surveillance & Epidemiology, explains the Emerging Drug Safety Technology Meeting (EDSTM) program and the application of artificial intelligence (AI) in pharmacovigilance: https://lnkd.in/eRg7K7GB
-
-
Today, the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the “Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles.” For a machine learning-enabled medical device, effective transparency ensures that information that could impact risks and patient outcomes is communicated to all the people who could be interacting with the device, including health care providers, payors, and others, to help make informed decisions. The Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles build upon the "Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles" and the "Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles" both published jointly by the FDA, Health Canada and MHRA. Transparency across health care is an international priority, and the FDA will continue to collaborate with international partners in this area. https://lnkd.in/dK-X6-Zw https://lnkd.in/ejqWRmV3
-
-
Today, FDA announced the issuance of warning letters to six online retailers for selling unauthorized e-liquid products from the Bad Drip brand that imitate prescription drug bottles. The retailers were also warned for selling unauthorized flavored, disposable e-cigarettes, including those under the brand names Funky Republic and HQD. https://lnkd.in/dsz_KY3W
-