Search Results for generic drug competition

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Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition By Zachary Brennan - Published 08 November 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition.

Categories: News, US, FDA, FTC, Generic drugs, Government affairs, Reimbursement

Tags: generic drug competition, REMS, shared REMS, pay-for-delay

Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting By Zachary Brennan - Published 20 September 2017

Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: REMS, Hatch-Waxman, generic drug competition

Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition By Zachary Brennan - Published 27 July 2016

The Federal Trade Commission (FTC) on Wednesday announced that generic drugmaker Teva Pharmaceuticals has agreed to sell its rights and assets to 79 pharmaceuticals to settle FTC charges that its proposed $40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anticompetitive.

Categories: News, US, FTC, Crisis management, Generic drugs, Manufacturing, Project management

Tags: Teva, Allergan, generic drugs, generic drug competition

New Senate Bill Aims to Close Regulatory Loopholes Blocking Generic Drug Competition By Zachary Brennan - Published 15 June 2016

Members of the Senate Judiciary Committee introduced bipartisan legislation on Tuesday that seeks to stop anticompetitive practices brand name drug companies often use to thwart or delay the entry of less-expensive generic versions of their products.

Categories: News, US, DOJ, FDA, FTC, Business and Leadership, Crisis management, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug competition, CREATES Act, REMS

FDA to Prioritize Generic Drug Applications for ‘Sole-Source’ Products By Zachary Brennan - Published 14 March 2016

The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic drug submissions for which there is currently only one manufacturer.

Categories: News, US, CDER, Generic drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drugs, generic drug competition, ANDA prioritization, FDA review of ANDAs

FTC Takes Action Against Pharmaceutical 'Product Hopping' By Zachary Brennan - Published 02 October 2015

The Federal Trade Commission (FTC) on Thursday criticized the way brand-name drug manufacturers often tweak products' formulations shortly before a generic's entry to market, thereby delaying competition.

Categories: News, US, FTC, Advertising and Promotion, Generic drugs, Due Diligence, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: product hopping, FTC, generic drug competition, Mylan, Warner Chilcott