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Blog & Resources Camargo Blog Regulatory

The Camargo Blog

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


September 14th, 2009

A Treatment IND is NOT the Same as an IND

September 10th, 2009

Comparability Protocols

September 8th, 2009

DESI Presentation: Q&A

September 1st, 2009

Test Specifications for Stability Studies

August 24th, 2009

FDA Halts Marketing of Topical Ibuprofen Products

August 7th, 2009

FDA Requests Melamine Testing of Ingredients

July 31st, 2009

Colchicine Tablets Approved

July 28th, 2009

BDSI’s Buccal Fentanyl 505(b)(2) NDA Approved

July 9th, 2009

Benzyl Alcohol—NME Approved Under 505(b)(2)

June 29th, 2009

Make the Most of Your Interactions With the FDA: FDA Meeting Requests

June 26th, 2009

Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities

June 12th, 2009

ANDA Suitability Petition vs 505(b)(2)

June 9th, 2009

Electronic Filing of eCTD INDs

June 8th, 2009

Writing and Submitting Electronic 505(b)(2) INDs

June 4th, 2009

Melphalan—New 505(b)(2) Orphan Designation

June 4th, 2009

Risk Evaluation Mitigation Strategy (REMS) for Long-Acting Opioids

May 15th, 2009

505(b)(2) IV Acetaminophen

May 15th, 2009

Quick-release Bromocriptine Mesylate Approved

May 4th, 2009

Polypill: a 505(b)(2) Candidate

April 13th, 2009

505(b)(2) Head Lice Treatment Approved

April 13th, 2009

Morphine Solution—FDA Changes Its Decision

April 1st, 2009

FDA Stops DESI Unapproved Rx Narcotics

February 28th, 2009

Generic Biologics

February 18th, 2009

Use of Data from Foreign Clinical Studies for US Approval

Page 8 of 10


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


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