laboratory of immunobiochemistry
Download
Skip this Video
Download Presentation
Laboratory of Immunobiochemistry

Loading in 2 Seconds...

play fullscreen
1 / 12

Laboratory of Immunobiochemistry - PowerPoint PPT Presentation


  • 179 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Laboratory of Immunobiochemistry' - Jims


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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
routine regulatory activities
“Routine” regulatory activities

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

Extracts

  • C11-cat
  • E7-Timothy
  • E4-cat hair
  • E8-Dp

Sera

  • S6-Dpf
planned replacements in 2009
Planned replacements in 2009
  • Sheep serum
    • S2b-cat
    • S3-cat
how do we manage the inventory
How do we manage the inventory?
  • Semi-annual reference checks
  • Estimate replacement dates based on expiry and consumption
  • Monitoring manufacturer requests
  • Limited distribution for research purposes
review responsibilities
Review Responsibilities

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
ad