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Blog & Resources Camargo Blog 505(b)(2) Development

The Camargo Blog

Get insight and information from our team of experts to improve your pharmaceutical development and commercialization strategy.


June 1st, 2008

What’s the Competition?

May 27th, 2008

Multiple RLD’s Under 505(b)(2)

May 26th, 2008

RLD—Born in the USA

May 18th, 2008

Paragraph IV Certifications Under 505(b)(2)

May 14th, 2008

Biovail to Reduce 505(b)(2) Development

May 14th, 2008

Fospropofol Turned Down or Approved by FDA Advisory Committee?

May 4th, 2008

Racemate > Isomer Approval Under 505(b)(2)

May 2nd, 2008

505(b)(2) RLD Patent Certification

April 23rd, 2008

505(b)(2) Patent & Marketing Exclusivity

April 16th, 2008

NanoNews—Beads Deliver Drug to Site of Action

April 15th, 2008

505(b)(2) Pre-IND Meetings Denied

April 15th, 2008

Is Your Drug Project a 505(b)(2), ANDA or OTC?

February 15th, 2008

Metabolites: New Safety Testing Requirements—Impact on 505(b)(2)

February 7th, 2008

A Single Phase 3 Trial Needed for 505(b)(2) Approval of a Combination Drug

January 30th, 2008

505(b)(2—Part 3: Pre-IND Submission & Meeting

January 17th, 2008

505(b)(2) with Only Phase 1 Study

January 16th, 2008

505(b)(2)—Part 2: The Assessment: Timeline, Cash Flows

December 19th, 2007

505(b)(2)—Part 2: The Assessment: CMC Development Plan

December 12th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Marketing Assessment

December 7th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Pharmacology

December 1st, 2007

505(b)(2)—Part 2: The Assessment: Pharmacokinetic Review

November 16th, 2007

505(b)(2) Combo Plavix/Prilosec

November 12th, 2007

505(b)(2)—Part 2: The Assessment: Preclinical Review/Preclinical Plan

November 8th, 2007

505(b)(2)—Part 2: The Assessment: Safety Review

Page 9 of 10


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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