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Contact FDA | FDAContact information for the U.S. Food and Drug Administration.
Warning Letters | FDAThe .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
Search for FDA Guidance Documents | FDASearch for official FDA guidance documents and other regulatory guidance.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgrMedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human
FDA Voices | FDAInsights from FDA leadership and experts into the agency s work on policy, consumer safety enforcement, medical products, food, tobacco.
FDA en español | FDALa FDA es responsable de proteger la salud pública asegurando la seguridad, eficacia y protección de los medicamentos, los productos biológicos y los dispositivos médicos humanos y veterinarios; y asegurando la seguridad
Public meeting: FDA Rare Disease Day 2024 - 03/01/2024 | FDAFDA will host Rare Disease Day, a virtual public meeting, on March 1, 2024 in global observance of Rare Disease Week. This year’s Rare Disease Day is dedicated to patients and health care professionals.
U.S. Food and Drug AdministrationThe 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 f
Electronic Common Technical Document (eCTD) | FDAElectronic Common Technical Document (eCTD) mandatory use for some submissions starts May 2017. eCTD is the standard format for electronic reg submissions.
Expiration Dating Extension | FDAIn some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability. Recognizing MCM stockpiling challenges, FDA is engaged, when
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