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Pediatric Exclusivity Statistics
submitted by healthnews 641 days ago (via fda.gov)
Pediatric Exclusivity Statistics (updated)
 
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Guidance for Industry
submitted by healthnews 641 days ago (via fda.gov)
Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1
 
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Drug Shortages: Current Drug Shortages; Argatroban Injection
submitted by healthnews 673 days ago (via fda.gov)
See Related information section
 
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Notice: FDA Annual Tissue Establishment Registration - Update
submitted by information 673 days ago (via fda.gov)
Please be advised that FDA will not be mailing the annual registration form to establishments that register electronically.
 
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Revised Instructions for Listing Other HCT/Ps on Form 3356 or in eHCTERS
submitted by information 673 days ago (via fda.gov)
Purpose: Many HCT/Ps are not specifically listed on the Form FDA 3356 or in eHCTERs and establishments are adding them utilizing various spellings and formats (currently we have a listing of over 70 “other products” that establishments have written in).
 
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Vaqta
submitted by information 152 days ago (via fda.gov)
 
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FDA issues warning letters to Bayer HealthCare for illegally marketing two unapproved drugs
submitted by healthnews 681 days ago (via fda.gov)
FDA issues warning letters to Bayer HealthCare for illegally marketing two unapproved drugs
 
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Residual Solvents in ANDAs: Questions and Answers
submitted by healthnews 681 days ago (via fda.gov)
Residual Solvents in ANDAs: Questions and Answers
 
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Important Notification
submitted by information 681 days ago (via fda.gov)
North American Coral Snake Antivenin (Micruris fulvius) (Equine) Lot 4030026
 
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FDA issues questions and answers on medication guides for erythropoiesis-stimulating agents (ESAs)
submitted by healthnews 647 days ago (via fda.gov)
FDA issues questions and answers on medication guides for erythropoiesis-stimulating agents (ESAs)
 
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