Search Results for generic drug approvals

Showing 1 – 6

Another Record Year for US Generic Drug Approvals in 2017 By Zachary Brennan - Published 05 October 2017

The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report.

Categories: News, US, CDER, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug approvals, GDUFA, 2017 generic drug approvals

Generic Drugs in 2017: FDA on Track for Most Approvals Ever By Zachary Brennan - Published 08 August 2017

Ten months into Fiscal Year 2017 and the US Food and Drug Administration (FDA) is on pace to break its record-setting year for abbreviated new drug application (ANDA) approvals from the last year.

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

Tags: generic drug approvals, ANDA approvals

FDA Speeding Generic Drug Approvals: Not Just Lip Service By Zachary Brennan - Published 10 July 2017

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: FDA generic drug approvals, GDUFA, ANDA approvals

FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals By Zachary Brennan - Published 08 November 2016

The US Food and Drug Administration (FDA) on Tuesday announced a final rule amending regulations on citizen petitions that would ensure the agency does not delay the approval of a pending generic drug or biosimilar because of such petitions, unless that delay is necessary to protect the public health.

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

Tags: PhRMA, citizen petitions, generic drug approvals

Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers By Zachary Brennan - Published 01 November 2016

As the debate over skyrocketing drug prices continues, at least one solution has cropped up in nearly every conversation: Reduce the generic drug backlog at the US Food and Drug Administration (FDA), create more competition and drug prices will come down.

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

Tags: generic drug approvals, drug prices, high drug prices, ANDA approvals, generic drug backlog, FDA backlog

Generic Drug Approvals Hit New Record in 2015, FDA Report Shows By Zachary Brennan - Published 13 April 2016

The US Food and Drug Administration (FDA) approved more generic drugs in 2015 than ever before and is on track to meet all of its goals from the Generic Drug User Fee Act of 2012 (GDUFA) by 2017, according to the first annual report from FDA’s Office of Generic Drugs (OGD).

Tags: generic drug approvals, ANDA backlog, OGD report