Search Results for ANDA

Showing 1 – 25  of 86

When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.

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

Tags: 505(b)(2) application, ANDA, FDA draft guidance

Status Updates for ANDAs: FDA Spells Out GDUFA II Provision By Zachary Brennan - Published 06 October 2017

Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs.

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

Tags: GDUFA II, ANDA status updates

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

Priority Generic Drug Reviews: New FDA Draft Guidance By Michael Mezher - Published 19 June 2017

In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.

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

Tags: Priority Generics, ANDA, Pre-Submission Facility Correspondence, PFC

Main Challenge for Generic Drugmakers? First Cycle Approvals, FDA Says By Zachary Brennan - Published 04 April 2017

The biggest outstanding challenge for the generic drug industry moving into the second iteration of its user fee agreement is multiple cycle reviews before approval, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs told participants Tuesday at a generic drugs forum for small businesses.

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

Tags: generic drugs, generic drug backlog, ANDA, abbreviated new drug applications

FDA Continues to Reduce Generic Drug Backlog By Zachary Brennan - Published 22 February 2017

The US Food and Drug Administration (FDA) on Wednesday revealed that it approved more than 700 abbreviated new drug applications (ANDAs) for generic drugs in 2016, though the number of ANDAs pending an industry response also rose by more than 700.

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

Tags: ANDA approvals, generic drug backlog, generic drug dashboard

FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017

The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals.

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

Tags: RLD, generic drugs, ANDA, ANDA submission

FDA Revises Refuse-to-Receive Guidance for ANDAs By Zachary Brennan - Published 21 December 2016

The second revision of the guidance, unveiled Wednesday, is part of the US Food and Drug Administration’s (FDA) attempt to assist abbreviated new drug application (ANDA) sponsors in understanding what deficiencies may cause FDA to refuse to receive (RTR) an ANDA.

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

Tags: ANDA, refuse-to-receive an ANDA, GDUFA, generic drugs

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

FY 2016 Generic Approvals by FDA: A New Record Under GDUFA By Zachary Brennan - Published 12 October 2016

The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014.

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

Tags: OGD, ANDA approvals, FDA approvals of generic drugs

Final FDA Rule Clarifies Pharma Patent Process With Aim of Reducing Unnecessary Litigation By Zachary Brennan - Published 05 October 2016

With the intent to cut back on the types of litigation that can delay the approval and marketing of generic drugs under 505(b)(2) applications and abbreviated new drug applications (ANDAs), the US Food and Drug Administration (FDA) on Wednesday released a final rule that revises and clarifies its regulations on a number of different parts of the pharmaceutical patent process.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drugs, ANDA approval, Orange Book, paragraph IV certifications

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

Impurity Deficiencies: How FDA Can Refuse-to-Receive an ANDA By Zachary Brennan - Published 24 August 2016

The US Food and Drug Administration (FDA) on Wednesday finalized guidance that will assist abbreviated new drug application (ANDA) submitters seeking approval for a new strength of a drug.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Quality, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: refuse-to-receive an ANDA, ANDA submission, generic drug submission

Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? By Zachary Brennan - Published 17 August 2016

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, pharmaceutical IP, generic drugs, ANDA approval process

FDA Approves First Generic Version of Roche’s Blockbuster Flu Treatment By Zachary Brennan - Published 04 August 2016

The US Food and Drug Administration (FDA) on Thursday announced that it has approved the first generic version of Roche’s Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older.

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

Tags: Tamiflu, Roche, Natco, ANDA approvals

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

Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn By Zachary Brennan - Published 08 July 2016

The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness.

Categories: News, US, FDA, Drugs, Labeling

Tags: generic drug labels, ANDA, withdrawn reference product

FDA Rejects Highest Number of Monthly Generic Drug Applications Ever By Zachary Brennan - Published 08 June 2016

The common refrain that the US Food and Drug Administration (FDA) has been approving an exorbitantly high number of drug applications for generic drugs, known as abbreviated new drug applications (ANDAs), to increase market competition in recent years is slowing down in recent months.

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

Tags: ANDA approvals, complete response letters, CRLs, generic drug applications

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

Grouping Supplements for CMC Changes: FDA Outlines New Policy By Zachary Brennan - Published 20 April 2016

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes to multiple approved new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biological license applications (BLAs) submitted by the same applicant.

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

Tags: CMC changes, NDA supplements, ANDA supplements, BLA supplements

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

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