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8
digs
Substantially Equivalent 510(k) Device - HCLL Transfusion, v3.0
submitted by information 484 days ago (via fda.gov)
Mediware Information Systems, Inc.
 
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3
digs
Postmarketing Study Commitments
submitted by healthnews 499 days ago (via accessdata.fda.gov)
Postmarketing Study Commitments quarterly update
 
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3
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submitted by healthnews 499 days ago (via )
 
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2
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CBER Foreign Regulators Seminar
submitted by information 510 days ago (via fda.gov)
Update
 
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2
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CBER 2007 Annual Report
submitted by information 510 days ago (via fda.gov)
Innovative Technology Advancing Public Health
 
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1
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Drugs Shortages: Resolved Drug Shortage
submitted by healthnews 418 days ago (via fda.gov)
Drugs@FDA Downloadable Data Files (updated)
 
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1
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Approval Information
submitted by information 418 days ago (via fda.gov)
Influenza Virus Vaccine (Afluria) - Annual Progress Report of Postmarketing Studies
 
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1
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Approval Information
submitted by information 418 days ago (via fda.gov)
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) - Summary Basis for Approval
 
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2
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Drug Master Files
submitted by healthnews 517 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 517 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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