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2
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Substantially Equivalent 510(k) Device - HCLL Transfusion, v3.0
submitted by information 652 days ago (via fda.gov)
Mediware Information Systems, Inc.
 
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2
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Postmarketing Study Commitments
submitted by healthnews 667 days ago (via accessdata.fda.gov)
Postmarketing Study Commitments quarterly update
 
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2
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submitted by healthnews 667 days ago (via )
 
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2
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CBER Foreign Regulators Seminar
submitted by information 678 days ago (via fda.gov)
Update
 
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2
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CBER 2007 Annual Report
submitted by information 678 days ago (via fda.gov)
Innovative Technology Advancing Public Health
 
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Drug Master Files
submitted by healthnews 685 days ago (via fda.gov)
Drug Master Files updated
 
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2
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Prescription Drug User Fee Act (PDUFA) Billable Products (updated)
submitted by healthnews 685 days ago (via fda.gov)
This list is intended to include all the Center for Drug Evaluation and Research (CDER) user fee billable therapeutic biological products and potencies approved under Section 351 of the Public Health Service Act.
 
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2
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The Adverse Event Reporting System (AERS) Latest Quarterly Data Files
submitted by healthnews 685 days ago (via fda.gov)
The Adverse Event Reporting System (AERS) Latest Quarterly Data Files
 
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Information for Healthcare Professionals Phenytoin and Fosphenytoin Sodium
submitted by healthnews 647 days ago (via fda.gov)
Phenytoin and Fosphenytoin Sodium associated with potential increased risk of serious skin reactions.
 
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