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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.
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
Employees at FDA
Updates
- FDA released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. This report aggregates metrics for regulatory activities supported by GDUFA research in three areas where the GDUFA Science and Research Program is expected to make an impact: ✅ Supporting the Pharmaceutical Development of Generic Drug Products ✅ Generating Evidence to Support the Timely Review and Approval of ANDAs ✅ Establishing More Efficient Approaches to Evaluate the Equivalence of Generic Drugs Read the FY23 GDUFA Science and Research Outcomes Report: https://lnkd.in/eCbDsJRG
- Watch our recorded webinar to find step-by-step information and best practices for completing and submitting Form FDA 1571 and IND cover letters for OTP-regulated products. And find other useful resources from our OTP Learn Course List! https://bit.ly/4dS1INE
OTP Learn fda.gov - The FDA’s Center for Devices and Radiological Health (CDRH) is announcing the expansion of the Total Product Life Cycle Advisory Program Pilot. Breakthrough Designated Devices reviewed in the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A) are eligible to enroll in the TAP Pilot. Find out more. https://lnkd.in/e7dhFvjGAdditionally, CDRH is providing a resource: TAP Pilot Engagement Tips that is intended to provide considerations that may help foster engagement between medical device sponsors and non-FDA parties including patients, payers, and health care providers during the medical device design and development process. https://lnkd.in/eKTz9Wiu
- Today, the FDA’s Human Foods Program #HFP is launching a new streamlined approach for handling and tracking complaints to improve the ability to detect and respond to problems involving FDA-regulated foods and dietary supplements, including infant formula. https://lnkd.in/eav44FC5Through this new process, the FDA will be better able to interface with consumers, learn new and valuable information about FDA-regulated products, and deliver on its mission to protect and promote public health through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure the safety of chemicals in food more effectively. There are now two ways to report food/dietary supplement issues: (1) through the #SafetyReportingPortal https://lnkd.in/dus53uu or (2) a call to 1-888-SAFEFOOD. NOTE: consumers and medical community who previously made reports through the FDA’s Office of Regulatory Affairs (ORA) hotline, should now use only 1-888-SAFEFOOD.
FDA Introduces Streamlined Complaint Process in new HFP fda.gov - Today, the first video in the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) educational video series was released. This first video titled, "Challenges, Strategies, and Regulatory Considerations for the Design of Rare Disease Clinical Trials” provides an overview of FDA’s regulatory requirements and strategies for clinical trial design. The ARC Program initiated LEADER 3D to better understand the unique challenges in bringing rare disease products to market. This video series and other educational resources will assist those navigating these scientific challenges and designing rare disease clinical trials that meet FDA’s regulatory requirements. Learn more & view video here: https://lnkd.in/eEW-xreB
- We are pleased to announce that today, the unified Human Foods Program, a new model for field operations and other modernization efforts is now in effect. This is the single largest reorganization in the agency’s modern history. https://lnkd.in/euaUwT7UThis will allow us to most effectively deliver on our mission to protect and promote public health through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure the safety of chemicals in our food.
- In observance of Breast Cancer Awareness Month, we would like to remind mammography facilities that the new requirements of the 2023 final rule amending the Mammography Quality Standards Act (MQSA) are now in effect. These include federal standards to incorporate current science and mammography best practices related to categorizing breast tissue density, enhancing communication to patients, and updating the quality standards for accreditation and facilities. Learn more: https://lnkd.in/eVXU5-6t
- 🎧 Talking to patients about their generic drugs improves usability, compliance, outcomes, & can save healthcare professional time in the future. Learn more in our “Q&A with FDA” podcast with Dr. Sarah Ibrahim from FDA’s Office of Generic Drugs: https://lnkd.in/e84P5vym
- The 2024 Food Facility Biennial Registration Renewal period starts tomorrow, October 1 and ends December 31. Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. For information on the renewal process >> https://lnkd.in/dhsbJsYYand a joint web presentation from the FDA and Dun & Bradstreet - https://lnkd.in/eFai6EKD
D&B + FDA Joint Web Presentation on Biennial Food Facility Registration Renewal
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Affiliated pages
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