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The Camargo Blog

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November 20th, 2009

Qutenza: Approval of a “DESI-inspired” Drug

November 4th, 2009

Does Europe Have a Pathway for Approval of Drugs Analogous to the FDA’s 505(b)2 Pathway?

November 3rd, 2009

FDA Refuse to File: Merck Zetia & Pfizer Lipitor

November 2nd, 2009

FDA Warns P&G Over Use of Drug + Vitamin C

October 30th, 2009

Reference Listed Drugs (RLDs): Can More Than One Be Used?

October 28th, 2009

505(b)(2) Submissions: No RLD

October 20th, 2009

505(b)(2) for Formulation Changes

October 8th, 2009

Allergan Sues FDA to Allow Off-Label Promotion

September 30th, 2009

Biosimilars—An introduction

September 10th, 2009

Comparability Protocols

September 8th, 2009

DESI Presentation: Q&A

September 1st, 2009

Test Specifications for Stability Studies

August 7th, 2009

FDA Requests Melamine Testing of Ingredients

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?

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