Navigating regulatory agencies can be a difficult and time consuming task. Below are some of the more useful websites that we have been using when trying to find key information. Please send any suggestions for additional websites that you find useful and we will add them to the list.
Official FDA Drug Labels http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10091
Unapproved Marketed Drugs FDA Website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm
International Guidelines for Safety, Efficacy and Quality from ICH http://www.ich.org/home.html
FDA and HHS Employee Directory and Phone Numbers http://directory.psc.gov/employee.htm
FDA Drug Approvals and Databases http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review at FDA http://www.fda.gov/ForPatients/Approvals/Fast/default.htm
Code of Federal Regulations Title 21 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
Structure and Content of Clinical Study Reports from ICH http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf
FDA Guidance to FDA Reviewers on How to Review a Clinical Trial and Write the Report http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0057-gdl0001.pdf
Pharmacy Compounding: The Compounding Quality Act of 2013 - FDA Webpage: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm
Meetings between FDA and Companies - FDA Guidance: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm153222.pdf
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