• WHAT IS 505(b)(2)?
  • SERVICES
    • Identify Viable Products
      • Feasibility
      • Pre-IND / Integrated Development Plan
      • Product Ideation
    • Develop Viable Products
      • Nonclinical Testing
      • CMC Development Services
      • Clinical Studies, Phases I-IV
    • Regulatory Strategy
      • FDA Meetings and Submissions
      • Additional Regulatory Services
  • 505(b)(2) BLOG
  • ABOUT US
    • Our History
    • Our Experience
    • Leadership Team
    • Press and News
    • Case Studies and White Papers
    • Events
  • CAREERS
  • CONTACT
  • WHAT IS 505(b)(2)?
  • SERVICES
    • Identify Viable Products
      • Feasibility
      • Pre-IND / Integrated Development Plan
      • Product Ideation
    • Develop Viable Products
      • Nonclinical Testing
      • CMC Development Services
      • Clinical Studies, Phases I-IV
    • Regulatory Strategy
      • FDA Meetings and Submissions
      • Additional Regulatory Services
  • 505(b)(2) BLOG
  • ABOUT US
    • Our History
    • Our Experience
    • Leadership Team
    • Press and News
    • Case Studies and White Papers
    • Events
  • CAREERS
  • CONTACT

505(b)(2) – Part 2: The Assessment: Overview

  • Posted by Ken Phelps
  • On November 1, 2007
  • Categories: 505(b)(2) Development, Product Selection and Planning, Services

Previous Post

505(b)(2) - Part 1: The overall process

Next Post

505(b)(2) - Part 2: The Assessment: Competitive Product(s) Review
505(b)(2) BLOG SEARCH
RECENT POSTS
  • Expedited Approval of FDA-approved Drugs in Australia
  • 505(b)(2) Application Changes: What You Need to Know
  • How Many FDA Premarket Applications Are Necessary For Your Combination Product?
  • Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and Drug Products
  • Effects on Combination Products: The Biologics Price Competition and Innovation Act of 2009
NEED HELP WITH 505(b)(2)?
BROWSE BY TOPICS
  • 505(b)(2) Development
  • Case Study
  • Clinical Studies, Phases I-IV
  • CMC
  • Combination Products
  • Commercialization
  • DESI Drug
  • Nonclinical Testing
  • Orphan Drug
  • Prodrug
  • Product Selection and Planning
  • Regulatory Strategy & Submissions
  • Services
  • Therapeutic Areas
TRUSTED RESOURCES
  • Center Watch Trial Listing
  • Drugs @ FDA
  • Electronic Orange Book
  • FDA Dockets Home Page
  • US Patent & Trademark Access

camargo pharma

Camargo Pharmaceutical Services provides comprehensive drug development services specialized for the 505(b)(2) approval pathway and analogous European processes.

Headquarters:
9825 Kenwood Road, Suite 203
Cincinnati, OH 45242

Durham Office
2505 Meridian Parkway, Suite 175
Durham, NC 27713

Phone: (513) 561-3329
Toll free: (888) 451-5708
Fax (513) 561-3367

The Latest From The Blog
  • Expedited Approval of FDA-approved Drugs in Australia
  • 505(b)(2) Application Changes: What You Need to Know
  • How Many FDA Premarket Applications Are Necessary For Your Combination Product?
  • Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and Drug Products
  • Effects on Combination Products: The Biologics Price Competition and Innovation Act of 2009
  • Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming
Additional Links
  • Home
  • In The News
  • Services
  • 505(b)(2) Blog
  • About Us
  • Camargo Careers
  • Contact Us
@2016 Camargo
Terms of Use | Privacy Policy