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2003N-0203: Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges; Public Workshop
Item Code
No.
Received Date
Submitter
Signature
FR Date
FR Page
Electronic Format
TS 13 07/21/2003 Innovative Systems for Delivery of Drugs and Biologics: Regulatory Challenges Patricia B. Shrader, AdvaMed    

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TS 12 07/21/2003 FDA Perspective on Review of Innovative Systems for Drug Delivery; Perspective from CDER's Division of Reproductive and Urologic Drug Products (DRUDP) Dan Shames, MD, CDER, FDA    

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TS 11 07/21/2003 Review Pathway for Photodynamic Therapy Systems Ricahrd P Felten, MS, CDRH, FDA    

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TS 10 07/21/2003 Innovative Systems for Delivery of Drugs and Biologics; Drug-Eluting Stents Current Approach to Review Ashley B Boam, CDRH, FDA    

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TS 9 07/21/2003 Office of Combination Products: Current Initiatives Mark D. Kramer, CDER, FDA    

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TS 8 07/21/2003 Indusry Perspective on Challenges for Product Developers - Drugs Christine Allison, MS, RAC, Eli Lilly and Company    

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TS 7 07/21/2003 Regulatory and Legal Challenges for Developers of Drug Delivery Devices Jonathan S. Kahan, Hogan & Hartson LLP    

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TS 6 07/21/2003 Surgeon's Perspective Paul Goldfarb, MD, FACS, Oncology Associates    

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TS 5 07/21/2003 An Perspective on Quality by Design: A Preclinical Opportunity Ajaz S. Hussain, PhD, CDER, FDA    

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TS 4 07/21/2003 Developing a Local Combination Product for Postoperative Atrial Fibrillation: Preclinical Progress and Challenges Kevin C. Skinner, VMD, Genzyme Corporation    

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TS 3 07/21/2003 Protein Delivery from Mechanical Devices; Challenges and Opportunities Bill Van Antwerp and Poonam Gulati, Medtronic Minimed    

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TS 2 07/21/2003 Preclinical Development considerations for the pulmonary delivery of drugs approved by other routes Chet Leach, Life Sciences Research and Development    

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TS 1 07/21/2003 Emerging Techniques and Technologies for Treatment of Solid Tumors Jonathan B Kruskal, MD, PhD, Beth Israel Deaconess Medical Center    

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TR 1 07/21/2003 Transcript of the July 8, 2003 Workshop      

Word

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Pages 1 - 100 pdf

Pages 101-200 pdf

Pages 201-300 pdf

Pages 301-400 pdf

Pages 401-424 pdf

NM 1       06/05/2003 33723

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Page last updated February 25, 2004

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