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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.

October 14th, 2009

Codeine Sulfate: FDA Continues Drive to Remove Unapproved Products, With a Twist

September 10th, 2009

Comparability Protocols

September 8th, 2009

DESI Presentation: Q&A

September 1st, 2009

Test Specifications for Stability Studies

July 31st, 2009

Colchicine Tablets Approved

July 29th, 2009

Scorecard of FDA Approvals Added

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 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

June 1st, 2009

What are DESI Drugs?

May 29th, 2009

MAP Pharmaceuticals 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals

May 15th, 2009

505(b)(2) IV Acetaminophen

May 11th, 2009

Multiple Dosage Strength Products—CMC Considerations

May 8th, 2009

505(b)(2) Combination Products

May 4th, 2009

Polypill: a 505(b)(2) Candidate

April 17th, 2009

505(b)(2) Program: BTG’s Paxclitaxel Gel for Oesophageal Cancer

April 13th, 2009

505(b)(2) Head Lice Treatment Approved

April 1st, 2009

FDA Stops DESI Unapproved Rx Narcotics

March 23rd, 2009

Generic Cliff

Page 7 of 10

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