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Found 8276 results for any of the keywords fda guidance documents. Time 0.010 seconds.
Search for FDA Guidance Documents | FDASearch for official FDA guidance documents and other regulatory guidance.
Medical Devices | FDAFDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products.
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
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
Microwave Ovens | FDAMicrowave oven manufacturers are required to certify their products and meet safety performance standards created and enforced by the FDA to protect the public health.
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
Protect Your Family From Fraudulent Flu Products | FDAInfluenza season may bring out dishonest sellers hawking fraudulent products that claim to prevent, treat, or cure the flu. These unproven products, sold online and in stores, haven’t been evaluated by the FDA for safety
COVID-19, Flu and RSV | FDACOVID, Flu and RSV vaccines, tests, and treatments - information about FDA-approved and authorized medical products for seasonal respiratory illnesses
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