We want to hear from you! Submit your comments on FDA’s recent draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.” When finalized, this guidance will describe FDA’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products. Read the draft guidance: https://lnkd.in/e4gzBYT7 Submit your comments by September 9, 2024: https://lnkd.in/d7cGAZSZ
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
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
-
To obtain feedback on possible considerations to help improve health outcomes across diverse populations, our Center for Devices and Radiological Health (CDRH) has released a new discussion paper on health equity for medical devices. The paper requests feedback on possible factors to consider when developing medical device clinical studies and evaluating devices. Learn more: https://lnkd.in/ef-PeHXS CDRH seeks input and feedback from the public. Please submit comments under docket number FDA-2024-N-3616 at https://lnkd.in/gR_Jfaw by October 4, 2024.
-
-
Check out the latest issue of the OCE PULSE for updates on FDA drug approvals in oncology and hematologic malignancies, public events, and professional training opportunities. Free subscription comes to your email once a month. Sign up today! https://lnkd.in/eH_PqDFr #OCEProjectSocrates
-
Learn how CDER researchers have helped to expand and refine clinical trial simulator tools to inform clinical trial planning in Alzheimer's disease, Parkinson’s disease, & Duchenne muscular dystrophy in this Regulatory Science Impact Story: https://lnkd.in/eB_MKfEK
-
-
#DigitalHealth is driving a revolution in health care and the FDA Center for Devices and Radiological Health (CDRH)continues to make strides in the advancement of digital health through ongoing activities within the program. https://lnkd.in/e9tEVgei
-
-
People who are pregnant or breastfeeding often need to take prescription medications. When the FDA approves a prescription medication for adults, the drug is also approved for pregnant patients, but information about medication dosing during pregnancy and breastfeeding may not be available. Efforts are underway at the FDA to increase the availability of high-quality data for medications people take while they are pregnant or breastfeeding. Check out this 2018 guidance on scientific and ethical considerations for including pregnant people in clinical trials: https://lnkd.in/egMCXE-N #WorldBreastfeedingWeek
-
Join us for the 26th Session of the International Medical Device Regulators Forum (IMDRF) starting on September 16. The first two days (Sept. 16-17) of the meeting are open to the public. The last three days (Sept. 18-20) are by invitation only. The FDA, as the 2024 Chair and Secretariat of the IMDRF, will host this free event. #MedicalDevice stakeholders — including regulators, industry, academia, and the media — are invited to attend virtually or in-person in Seattle, Washington. Register before August 26. Learn more:
-
-
Today, we approved a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma. Synovial sarcoma is a rare form of cancer in which malignant cells develop and form a tumor in soft tissues of the body. https://lnkd.in/e9_Mh_av
-
-
#DYK Federal law authorizes the FDA to charge a fee for medical device product review and establishment registration? Find out more about the #MedicalDevice user fees, annual establishment registration fees, and the small business program for FY2025. https://lnkd.in/ebC6Ke-E
-
-
Save the date! On September 25, 2024, FDA will hold a public meeting on the "Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food." This is part of our larger enhanced approach for food chemical safety. https://lnkd.in/eXvpcr4J
-