Accessdata.fda.gov

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Drug Notifications - Food and Drug Administration

Dec 08, 2016 · U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

https://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm 

Www.accessdata.fda.gov

Additions and/or revisions underlined: The following adverse reactions have been observed in the postmarketing setting: hepatic failure, lacrimal duct stenosis …persistent or severe hand-and-foot syndrome can eventually lead to loss of fingerprints.In instances of exposure to crushed XELODA tablets, the following adverse reactions have been reported: eye irritation and …

https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=downloadDetails.page&DrugNameID=614 

FDA Industry Systems

FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. FIS has been available 24 hours a day, seven days a week, since October 16, 2003 6:00 p.m. EDT. FIS was created, in part, in response to the Bioterrorism Act of 2002

https://www.access.fda.gov/ 

Frequently Asked Questions | FDA

Feb 21, 2020 · ESG recommends that you send an email to [email protected] for all submissions over 10 GB of uncompressed data. I cannot download the WebTrader client installer from https://esgtest.fda.gov

https://www.fda.gov/industry/create-esg-account/frequently-asked-questions 

Medical Devices | FDA

Contact Us. Division of Industry and Consumer Education. Center for Devices and Radiological Health. Food and Drug Administration. 10903 New Hampshire Ave. Silver Spring, MD 20993. [email protected]

https://www.fda.gov/Medical-Devices 

Electronic Common Technical Document (eCTD) | FDA

Electronic Common Technical Document (eCTD) mandatory use for some submissions starts May 2017. eCTD is the standard format for electronic reg submissions.

https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd 

Health Fraud Product Database | FDA

New Drug/Misbranded: Warning Letter: Foods 09/10/2021 “Eye-C” Holographic Health, Inc. 516 E. Market Street Kingsport, TN 37660: holographichealth.com: New Drug/Misbranded: Warning …

https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database 

How to Make a FOIA Request | FDA

Mar 12, 2020 · Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332)

https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request