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The Camargo Blog

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March 27th, 2013

Orphan Designation Granted Letter

March 25th, 2013

Are 505(b)(2)’s “Super Generics” or What Do We Call Them?

March 22nd, 2013

K-V Appeals Makena Decision

February 11th, 2013

No 5-Year Exclusivity for Combinations Drugs with an NCE

January 18th, 2013

2013 GDUFA Fees

January 2nd, 2013

2012 505(b)(2) Approvals—Record Year

December 16th, 2012

Suit to Challenge Use of REMS to Block Generics and 505(b)(2)

September 26th, 2012

Orphan Designation without Exclusivity: Court Asked to Decide

September 25th, 2012

New Generic Stability Requirements

September 7th, 2012

Court Dismisses K-V’s Suit Against FDA

August 8th, 2012

K-V Pharma Bankrupt—Claims FDA Doesn’t Back Makena

July 16th, 2012

Generic of 505(b)(2)

June 18th, 2012

REMS in Congress

April 30th, 2012

ViroPharma Loses Exclusivity Appeal

April 19th, 2012

ViroPharma Denied Request for 3-year Exclusivity

April 15th, 2012

Drug Development Planned Like the Titanic

April 12th, 2012

NIH Head Urges Repositioning/Repurposing

April 2nd, 2012

Generic vs. 505(b)(2) Failure-to-Warn Liability

January 9th, 2012

2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals

December 21st, 2011

What is an Approved DESI Product?

October 4th, 2011

Stability Changes Coming to ANDAs

October 3rd, 2011

Don’t Launch Unapproved Products After 9/19/2011

September 11th, 2011

AB Rated 505(b)(2)’s

August 7th, 2011

2012 PDUFA User Fees

June 24th, 2011

Whew! Supreme Court Rules Generic Labels Must Track RLD

June 14th, 2011

K-V’s Makena Part 4: Statistical versus Clinical Significance

June 9th, 2011

Patent Cliff Causes Pfizer Cuts

June 8th, 2011

Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products

June 2nd, 2011

Ophthalmics: 21 CFR 314 94(a)(9)(iv) No Longer Applies

June 2nd, 2011

Why Generic Companies Might Like 505(b)(2)

May 31st, 2011

K-V’s Makena: Part 3: Use of Public Information for 505(b)(2) Approvals

May 23rd, 2011

K-V’s Makena Part 2: Accelerated Approval Subpart H

May 18th, 2011

K-V’s Makena® Part 1: 505(b)(1) or 505(b)2)?

May 16th, 2011

K-V’s Makena®: A trove of 505(b)(2) Lessons

March 23rd, 2011

Revised Safety Reporting for BE/BA Studies Effective March 28, 2011

March 10th, 2011

User Fee Waivers: What is an Affiliate? New Guidance Issued

February 21st, 2011

Approvals of ANDAs Slows

February 7th, 2011

Mitosol—An Orphan & 505(b)(2) without clinical studies

February 1st, 2011

Injectables: 505j or 505(b)(2)?

January 19th, 2011

REMS for 505(b)(2) Products?

January 6th, 2011

2010 505(b)(2) Approvals

December 20th, 2010

PDUFA Fee Waiver: Plan Ahead

Page 5 of 10

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

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