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Home
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» Hatch Waxman Act
Hatch Waxman Act
FDA seeks input on pre-Hatch-Waxman ‘PANDA’ applications
RAPS.org
Thu, 08/12/21 - 10:56 pm
FDA
Hatch Waxman Act
generics
PANDAs
Is Congress Poised to Deal a Significant Blow to Hatch-Waxman and the Generic Drug Industry?
FDA Law Blog
Tue, 12/10/19 - 10:11 am
FDA
drug pricing
Hatch Waxman Act
legislation
regulatory
generics
Drugmakers master rolling out their own generics to stifle competition
Fierce Pharma
Mon, 08/5/19 - 10:39 am
generics
PDL Biopharma
Tekturna
Hatch Waxman Act
FTC Finds Dwindling Number of Anticompetitive Reverse Payment Deals
RAPS.org
Thu, 05/23/19 - 10:58 pm
FTC
Hatch Waxman Act
anticompetitive practices
[sponsored] Orange Book Companion® Adds New Features and Capabilities
CP Wire
Wed, 09/5/18 - 01:50 pm
patents
Hatch Waxman Act
FDA
exclusivity
[sponsored] Orange Book Companion® Adds New Features and Capabilities
Wed, 09/5/18 - 01:40 pm
patents
Hatch Waxman Act
FDA
exclusivity
Biosimilars and Complex Generics Uptake Not as Expected – Why is that a Surprise?
Lachman Consultants
Mon, 08/13/18 - 06:04 pm
biosimilars
Hatch Waxman Act
generics
Interview With Hatch-Waxman Expert Kurt Karst
CP Wire
Tue, 04/24/18 - 07:59 pm
FDA
Hatch Waxman Act
patents
The FTC Appeals Shire ViroPharma Dismissal
FDA Law Blog
Thu, 04/19/18 - 09:08 am
FTC
Shire
ViroPharma
Hatch Waxman Act
FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision
FDA Law Blog
Wed, 08/16/17 - 10:03 am
FDA
Xtampza ER
Hatch Waxman Act
exclusivity
Despite scoring an FDA nod, Merck's biosim Lusduna must wait to challenge Lantus
Fierce Pharma
Sun, 07/23/17 - 11:40 am
FDA
Merck
biosimilars
Lusduna Nexvue
Lantus
diabetes
Sanofi
Hatch Waxman Act
FDA’s Hatch-Waxman Public Meeting and Progression of the Agency's Drug Competition Action Plan
FDA Law Blog
Wed, 07/19/17 - 09:56 am
FDA
Hatch Waxman Act
Scott Gottlieb
A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access
FDA Law Blog
Thu, 06/22/17 - 09:33 am
FDA
innovation
drug access
Hatch Waxman Act
Is a Hatch-Waxman 30-Month Stay Terminated if the Dismissal of a Patent Infringement Action is Later Vacated? FDA Says “No”
FDA Law Blog
Wed, 03/29/17 - 09:03 am
Hatch Waxman Act
patents
FDA
Collegium Pharmaceutical
Xtampza ER
21st Century Cures Act adds Hatch-Waxman rule to drug-device combos
Mass Device
Tue, 12/20/16 - 12:03 pm
21st Century Cures Act
Hatch Waxman Act
devices
generics
drug-device combos
Is the Hatch-Waxman System Broken?
Pharm Exec
Thu, 01/7/16 - 12:59 pm
Hatch Waxman Act
generics
R&D
It’s Been One of “Those Weeks” in Hatch-Waxman World: Another Two Lawsuits and Two Court Decisions
FDA Law Blog
Fri, 05/1/15 - 10:11 am
FDA
Hatch Waxman Act
Spectrum Pharmaceuticals
Boehringer Ingelheim
Otsuka
Inside the FDA labeling fight that could upend the generics market
BioPharma Dive
Wed, 04/8/15 - 10:37 am
FDA
labeling
generics
Hatch Waxman Act
OxyContin, Cialis Makers Dodge Court to Beat Patent Suits
Bloomberg
Fri, 10/3/14 - 04:41 pm
oxycontin
Cialid
patents
Hatch Waxman Act
Purdue Pharma
The Supreme Court & How To Delay Generics, Pt. 2
Pharmalot
Fri, 05/27/11 - 09:10 am
generics
Supreme Court
Hatch Waxman Act