Company intelligence
FDA
About FDA
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.
Verified activity
Signals from FDA
19 published signals
Presence & Recognition
FDA is hosting a public workshop on Testosterone Use in Menopausal Women at the Office of Women’s Health and the Center for Drug Evaluation and Research.
Reported by FDA
Legal & Regulatory
FDA is opening a public docket for 60 days for stakeholders to submit comments on Testosterone Use in Menopausal Women by October 19.
Reported by FDA
Research & Knowledge
FDA released its 2025–2030 Strategic Plan for the Accelerating Rare disease Cures Program, a five-year roadmap to accelerate the development of safe and effective treatments for rare diseases.
Reported by FDA
Presence & Recognition
FDA is hosting an in-person workshop for company participants involved in complex generics, featuring informal conversations with FDA experts from review divisions assessing ANDAs for generic inhalation products.
Reported by Sam Raney, PhD
Presence & Recognition
FDA regulatory inspections and enforcement advice is provided by Canal Row Advisors.
Reported by Vid Desai
Legal & Regulatory
FDA issued guidance titled Temporary Policies for Compounding Certain Starter Parenteral Nutrition Products for Neonates to describe temporary regulatory and enforcement priorities for state-licensed pharmacies, federal facilities, and outsourcing facilities compounding specified parenteral drugs under sections 503A and 503B of the FD&C Act.
Reported by FDA
Legal & Regulatory
FDA granted accelerated approval to Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer who develop an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy.
Reported by FDA
Legal & Regulatory
FDA expanded oversight of foreign clinical trial sites, added inspection resources, and increased scrutiny of data from sites not accessible to the FDA.
Reported by FDA
Legal & Regulatory
FDA approved an injection for the treatment of Alexander disease in pediatric and adult patients for the first time.
Reported by FDA
Legal & Regulatory
FDA published an update regarding clinical trial site inspections to ensure compliance and data integrity in successful drug development.
Reported by Chongwoo Yu
Research & Knowledge
FDA published a new paper titled AI cautionary guide pitfalls and strategies.
Reported by Qi Liu
Research & Knowledge
FDA updated the lists of medical devices incorporating digital health technology.
Reported by John Nicol
Legal & Regulatory
FDA closed its investigation into the outbreak of Salmonella Enteritidis infections linked to recalled shell eggs.
Reported by FDA
Legal & Regulatory
FDA issued an Emergency Use Authorization for Capstar (Nitenpyram) tablets for the prevention and treatment of New World screwworm infestations in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old.
Reported by FDA
Legal & Regulatory
FDA is adding resources and expanding foreign BIMO inspections, including early-phase and Phase 1 trials, to scale with global science and risk.
Reported by Lowell M. Zeta
Legal & Regulatory
FDA approved the first treatment for pediatric and adult patients with Alexander disease.
Reported by Emily Freilich, M.D.
Presence & Recognition
FDA is scheduled to host a three-week workshop for GLP-1 generic applications.
Reported by Sam Raney, PhD
Presence & Recognition
FDA is hosting two virtual and in-person sessions called Ask the FDA to answer questions from virtual and in person attendees.
Reported by Sam Raney, PhD
Presence & Recognition
FDA is hosting a dedicated in-person session for in-person attendees to meet informally with FDA regulators from all the divisions that review GLP-1 generic applications.
Reported by Sam Raney, PhD