Search Results for ANDA backlog

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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

FDA Continues Steady Reduction of Generic Drug Application Backlog By Zachary Brennan - Published 25 July 2016

As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs).

Categories: News, US, FDA, Crisis management, Generic drugs, Due Diligence, Government affairs, Manufacturing

Tags: ANDA backlog, generic drug approval, Woodcock, JAMA

Woodcock: FDA Hits ANDA Backlog Reduction Goal Ahead of Schedule By Zachary Brennan - Published 11 July 2016

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported on Monday via email that as of 1 July 2016, CDER has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog, thereby accomplishing the agency’s backlog commitment more than one year ahead of schedule. 

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

Tags: GDUFA, ANDA backlog, generic drug user fees

FDA Slowly Chips Away at ANDA Backlog By Zachary Brennan - Published 02 May 2016

Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday.

Categories: News, US, CDER, Compliance, Generic drugs, Due Diligence, Government affairs, Submission and registration

Tags: ANDA backlog, generic drug applications, FDA generic approvals

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

FDA to Congress: GDUFA is Working By Zachary Brennan - Published 30 March 2016

A little more than three years into the user fee program for generic drugs, created under the Generic Drug User Fee Amendments (GDUFA) of 2012, and the US Food and Drug Administration (FDA) is telling Congress that following a major restructuring, the program is working.

Categories: News, US, FDA, Compliance, Generic drugs, Due Diligence, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: generic drugs, GDUFA, generic drug user fees, ANDA backlog

Generic Drug Review Dashboard: FDA Offers a First Look By Zachary Brennan - Published 10 February 2016

As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs).

Categories: News, US, FDA, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: generic drug review, ANDA backlog, FDA and ANDAs, generic drug applications

What FDA Can and Can’t Do to Help Lower Rising Drug Prices By Zachary Brennan - Published 18 November 2015

Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview.

Categories: News, US, FDA, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: FDA, drug pricing, Robert Califf, Bernie Sanders, drug imports, ANDA backlog, generic drugs

Senator Calls on FDA to Reduce ANDA Backlog By Zachary Brennan - Published 06 October 2015

As soaring drug prices remain in the national spotlight, the US Food and Drug Administration (FDA) needs to do what it can to reduce its backlog of generic drug applications, Sen. David Vitter (R-LA) said in a letter to FDA Acting Commissioner Stephen Ostroff.

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

Tags: OGD, ANDA backlog, Vitter, Louisiana, generic drugs