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Laboratory of Immunobiochemistry. Ronald L. Rabin, MD Allergenic Products Advisory Committee 18 March 2009. Laboratory of Immunobiochemistry. Ronald L. Rabin, MD - Lab Chief Jay E. Slater, MD – Supervisory Medical Officer Nicolette deVore, PhD – Staff Fellow

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Laboratory of immunobiochemistry

Laboratory of Immunobiochemistry

Ronald L. Rabin, MD

Allergenic Products Advisory Committee

18 March 2009


Laboratory of immunobiochemistry1
Laboratory of Immunobiochemistry

  • Ronald L. Rabin, MD - Lab Chief

  • Jay E. Slater, MD – Supervisory Medical Officer

  • Nicolette deVore, PhD – Staff Fellow

  • Sandra Menzies, MS, Consumer Safety Officer

  • Katya Dobrovolskaia – Biologist

  • Mona Febus – Microbiologist

  • Cherry Valerio – Biologist

  • Aaron Chen – Biologist

  • Viraj Mane, PhD

  • Zeng Zhao, MD

  • Philippa Hillyer, PhD

  • Nataly Raviv

  • Lynnsie Schramm


Division of bacterial parasitic and allergenic products
Division of Bacterial, Parasitic, and Allergenic Products

  • Milan Blake, PhD, Director

  • Jay E. Slater, MD, Deputy Director

  • Jennifer Bridgewater, MPH, Associate Director for Regulatory Policy

  • Tina Roecklein, MS, Regulatory Coordinator


Division of vaccines and related products applications dvrpa
Division of Vaccines and Related Products Applications (DVRPA)

  • Wellington Sun, MD, Director

  • Paul Richman, PhD, Chief, Regulatory Review Branch

  • CDR Colleen Sweeney, MS, Regulatory Health Project Coordinator

  • LCDR Jason Humbert, RN, Regulatory Project Manager

  • CDR Joseph Temenak, PhD, Regulatory Review Officer

  • LCDR Michael Smith, PhD, Regulatory Review Officer

  • LT Elizabeth Valenti, Regulatory Review Officer


Cber lab senior staff have dual responsibilities

CBER Lab Senior Staff have dual responsibilities (DVRPA)

Regulatory/review

Research


Routine regulatory activities
“Routine” regulatory activities (DVRPA)

Lot release

  • 2008: 390 Protocols Reviewed

    Reference distribution

  • 2008: 2480 vials in 132 shipments sent to manufacturers (through 10/07/08)

    Reference maintenance

  • semiannual checks

  • replacement




References replaced in 2008
References replaced in 2008 (DVRPA)

Extracts

  • C11-cat

  • E7-Timothy

  • E4-cat hair

  • E8-Dp

    Sera

  • S6-Dpf


Planned replacements in 2009
Planned replacements in 2009 (DVRPA)

  • Sheep serum

    • S2b-cat

    • S3-cat


How do we manage the inventory
How do we manage the inventory? (DVRPA)

  • Semi-annual reference checks

  • Estimate replacement dates based on expiry and consumption

  • Monitoring manufacturer requests

  • Limited distribution for research purposes


Review responsibilities
Review Responsibilities (DVRPA)

Investigational New Drug (IND)

  • Sponsor originated (goal is licensure/market)

  • Investigator originated (use of extract for purpose other than licensed)

    • nasal or bronchial challenges

    • mechanistic studies

      Biological License Applications (BLA)

  • Initial License

  • Supplements

  • Annual Reports

    Consultations for other centers

  • CDER

  • CDRH


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