Search Results for Office of Generic Drugs

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FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week’s Hearing By Zachary Brennan - Published 24 February 2017

While reporting a US savings of $1.68 trillion over the last 10 years for generic drugs, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD), also unveiled statistics for another record-setting year in generic drug approvals.

Categories: News, US, FDA, Generic drugs

Tags: Office of Generic Drugs, GDUFA, BsUFA

FDA Kicks off Generic Drug User Fee Reauthorization Process By Alexander Gaffney, RAC - Published 21 April 2015

Regulators and generic pharmaceutical companies, start your engines. The race to the next reauthorization of the Generic Drug User Fee Act (GDUFA) has begun.

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

Tags: GDUFA, Generic Drug User Fee Act, Office of Generic Drugs

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

FDA Plans Studies into Problems Affecting Complex Generic Drugs By Alexander Gaffney, RAC - Published 25 March 2015

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is preparing to fund studies to develop models to better evaluate generic drugs, including modified-release drugs and several popular oral anticoagulants.

Categories: News, US, CDER, Generic drugs

Tags: Office of Generic Drugs

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