Search Results for OGD

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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

Former FDA Deputy Director Charged With Insider Trading for Leaking Non-Public Approval Information By Zachary Brennan - Published 15 June 2016

A former Deputy Director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) was charged on Wednesday for providing tips on drug approvals to three hedge fund managers that made tens of millions off of the non-public information.

Categories: News, US, CDER, Clinical, Crisis management, Drugs

Tags: FDA, OGD, insider trading, FDA non-public information, securities trading with non-public information

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

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

FDA to Approve ANDAs on the Basis of Draft Labeling By Zachary Brennan - Published 05 October 2015

The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling.

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

Tags: ANDA, draft labeling, drug labels, FDA guidance, FPL, OGD

Temporary Reshuffle at FDA's Office of Generic Drugs as Leader Takes Medical Leave By Alexander Gaffney, RAC - Published 30 March 2015

The US Food and Drug Administration's (FDA) top generic drug regulator, Kathleen "Cook" Uhl, is temporarily stepping down to deal with a serious health issue, FDA has confirmed.

Categories: News, US, CDER, Generic drugs

Tags: OGD, Office of Generic Drugs, Kathleen Uhl

Facing Key Challenges, FDA's Office of Generic Drugs Seeks Deputy Director By Alexander Gaffney, RAC - Published 25 February 2015

The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), fresh off the appointment of a permanent director last month, is hoping to hire someone to act as the office's second-in-command.

Categories: News, US, CDER, Generic drugs

Tags: OGD, Office of Generic Drugs, OGD Deputy Director

Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies By Alexander Gaffney, RAC - Published 06 February 2015

The US Food and Drug Administration (FDA) is allowing more time for industry stakeholders and the public to weigh in on whether new regulations or policies are needed to oversee the generic pharmaceutical industry.

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

Tags: GDUFA, ANDA, Guidance, Abbreviated New Drug Application, Office of Generic Drugs, OGD

On a Hiring Spree, FDA Hires Almost 1,000 New Generic Drug Regulators By Alexander Gaffney, RAC - Published 19 January 2015

If you're a regulatory professional whose job includes working with the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), you might be seeing some new names and faces in your interactions with the agency—about a thousand of them, in fact.

Categories: News, US, CDER, Talent Recruiting, Generic drugs

Tags: GDUFA, Hiring, OGD, Office of Generic Drugs

After Two-Year Search, FDA's Office of Generic Drugs Hires Permanent Leader By Alexander Gaffney, RAC - Published 15 January 2015

The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD)—the office charged with overseeing and approving all generic drug products in the US—is finally getting a permanent leader, the agency has confirmed.

Categories: News, US, CDER, Generic drugs

Tags: OGD, Office of Generic Drugs, Kathleen Uhl

After 'Arduous' Setbacks, FDA's Generic Drug Strategy Takes Shape in New Leadership By Alexander Gaffney, RAC - Published 21 July 2014

The US Food and Drug Administration's (FDA) long-awaited reorganization of its Office of Generic Drugs (OGD) is finally getting underway, the agency said in a statement today.

Categories: News, US, CDER, Generic drugs

Tags: OGD, Office of Generic Drugs, Janet Woodcock, ORS, OB, OGDP, ORO, Super Office

Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex By Alexander Gaffney, RAC - Published 29 April 2014

Categories: US, FDA

Tags: Patent Reissue, Generic Drug, 180-Day Exclusivity, Mylan, Lawsuit, OGD, ANDA, Latest News, pharmaceutical

FDA Clears Way for Generics of 26 Popular Drugs By Alexander Gaffney, RAC - Published 03 April 2014

Categories: US, FDA, CDER

Tags: BE Recommendations, Generic Drug, BE, OGD, Latest News, pharmaceutical, bioequivalence, drug

Citing Differences, FDA Generics Director Greg Geba to Resign By Alexander Gaffney, RF News Editor - Published 13 March 2013

Categories: FDA, CDER

Tags: OPS, Woodcock, Generic, OGD, pharmaceutical, drug

New FDA Staff Policy Manual Defines 'Major Amendments' to Generic Drug Submissions By Alexander Gaffney - Published 04 October 2012

Categories: FDA

Tags: Minor Amendment, Major Amendment, Amendments, MAPP, Generic, OGD, ANDA, Latest News, pharmaceutical, drug, review

New Draft Stability Guidance Calls for Use of ICH Standards By Alexander Gaffney - Published 25 September 2012

Categories: FDA, CDER, ICH

Tags: Stability Testing, ANDAs, OGD, ANDA, Latest News, draft guidance, guidance

Woodcock Proposes Creation of Generics Super Office, New Office of Drug Quality By Alexander Gaffney - Published 10 September 2012

Categories: FDA, CDER

Tags: Super Office, Geba, OPS, Woodcock, OGD, Latest News, Generics

Office of Generic Drugs Receives New Director By Alexander Gaffney - Published 16 July 2012

Categories: FDA, CDER

Tags: Geba, OPS, Director, OGD, Latest News

CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements By Alexander Gaffney - Published 01 May 2012

Categories: FDA

Tags: Extraordinary Hardship, Appeal, Expedited Review Request, Supplement, MAPP, ANDAs, OGD, ANDA, Latest News, staff

FDA: Tablet Size Matters for Generics By Alexander Gaffney - Published 06 January 2012

Categories: FDA

Tags: Size, Generic, RLD, OGD, ANDA, Tablet, Latest News