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CBER Index

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RabAvert (Rabies Vaccine)

Rabies Vaccine (RabAvert)

Recalls / Withdrawals

Recombivax (Hepatitis B Vaccine (Recombinant))
     8/27/1999 Supplement
     9/23/1999 Supplement

ReFacto (Antihemophilic Factor (Recombinant))

Refusal to File / Clinical Hold Meetings

Registration
     Blood Establishment
     Tissue and Human Cell Establishment

Report to Congress: Reports on Postmarketing Studies [FDAMA 130]

Report to the Biologics Community (PDF), (Text)

Reporting Biological Product Deviations

Research

Respigam (Respiratory Syncytial Virus Immune Globulin Intravenous (Human))

Respiratory Syncytial Virus Immune Globulin Intravenous (Human) (Respigam)

Rho(D) Immune Globulin Intravenous (Human) (Rhophylac)

Rhophylac (Rho(D) Immune Globulin Intravenous (Human)

RotaShield (Rotavirus Vaccine, Live, Oral, Tetravalent)

Rotavirus Vaccine, Live, Oral, Tetravalent (RotaShield)

Rules, Final and Proposed

Safety Information

SARS (Severe Acute Respiratory Syndrome)

Scientific / Regulatory Information Meetings

Sepacell Pre-Storage Leukocyte Reduction Set for Red Cells

Severe Acute Respiratory Syndrome (SARS)

Shortage Information

Smallpox

Smallpox Vaccine, Dried, Calf Lymph Type (Dryvax)
      10/25/2002 Supplement
      6/26/2003 Supplement
      11/5/2004 Supplement

Stakeholders Information

Standard Operating Procedures and Polices

Substantially Equivalent 510(k) Device Information

Summaries / Presentations

 

 
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