Search Results for generic competition

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FDA Plots Policy Priorities for 2018 By Zachary Brennan - Published 11 January 2018

The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: generic competition, total product lifecycle, opioids

Report Highlights Cracks in the Market for Generic Competition By Michael Mezher - Published 02 August 2017

As the US Food and Drug Administration (FDA) looks for ways to boost generic competition, a new working paper published by the National Bureau of Economic Research (NBER) suggests that competition among generic drugmakers slows over time, potentially leading to higher prices for older treatments and drug shortages.

Categories: News, US, FDA, Generic drugs

Tags: Generic Competition, National Bureau of Economic Research

Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse By Michael Mezher - Published 26 June 2017

In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: REMS, Generic Competition

GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process By Zachary Brennan - Published 26 September 2016

On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering eight-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Manufacturing

Tags: ANDA backlog, generic drug reviews, generic competition

Authorized Generics: Why Mylan Would Compete With Itself in the EpiPen Market By Zachary Brennan - Published 29 August 2016

As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced on Monday that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-name product.

Categories: News, US, FDA, Generic drugs, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: Mylan, EpiPen, generic competition, authorized generics

Congressional Support for Priority Review Vouchers Presses On Despite FDA Qualms By Zachary Brennan - Published 18 March 2016

Almost a decade into the experiment of offering lucrative priority review vouchers (PRVs) to help speed the development of treatments for neglected tropical and pediatric diseases and it seems Congress’s love of the vouchers has only just begun.

Categories: News, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: generic competition, priority review voucher, PRV program, Zika PRV, generic PRV

FTC: Pay-For-Delay Deals Decrease Significantly After Supreme Court Ruling By Zachary Brennan - Published 14 January 2016

The number of pay-for-delay settlements decreased significantly in 2014 after a Supreme Court decision in 2013 found that a branded drug manufacturer’s reverse payment to a generic competitor to settle patent litigation can violate antitrust laws.

Categories: News, US, FTC, Drugs, Ethics, Government affairs, Regulatory strategy

Tags: FTC, pay-for-delay, generic competition

New Calls for Supreme Court to Weigh in on Unilateral Drug Labeling, 'Product Hopping’ By Zachary Brennan - Published 10 November 2015

The US Supreme Court is considering two requests that could have an impact on US Food and Drug Administration (FDA) rules governing drug label changes, and whether brand name drug manufacturers have to take generic competition into account when pulling a product from the market.

Categories: News, US, FDA, FTC, Compliance, Drugs, Due Diligence, Labeling, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Johnson & Johnson, Motrin, drug labels, FDA, product hopping, generic competition