Search Results for Janet Woodcock

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FDA's Woodcock: The Clinical Trials System is 'Broken' By Zachary Brennan - Published 20 September 2017

The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine on Wednesday.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Government affairs

Tags: Janet Woodcock, real world evidence, real world data, drug development

'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017 By Michael Mezher - Published 15 December 2016

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Submission and registration

Tags: CDER 2017 Priorities, 21st Century Cures, PDUFA, GDUFA, BsUFA, Janet Woodcock

Woodcock on Biosimilars: Earning the Trust of Prescribers and Patients is Key By Zachary Brennan - Published 07 September 2016

Similar to earning the public’s trust and confidence on generic drugs more than 20 years ago, the biosimilar industry needs to work to establish the same pattern of trust and confidence now, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, told attendees at the Generic Pharmaceutical Association’s (GPhA) biosimilar conference in Bethesda, MD, on Wednesday.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs, Quality

Tags: Janet Woodcock, GPhA, biosimilars, biosimilar education

Woodcock: Antibiotics Pipeline is 'Fragile and Weak' By Michael Mezher - Published 14 June 2016

At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections.

Categories: News, US, FDA, Clinical, Drugs, In vitro diagnostics, Preclinical, Research and development

Tags: Antimicrobial Resistance, AMR, Antibiotics, Janet Woodcock, Energy & Commerce Committee, GAIN Act, ADAPT Act

Real World Evidence: Can it Support New Indications, Label Expansions? By Michael Mezher - Published 10 March 2016

At a public workshop in Washington, DC last week, top US Food and Drug Administration (FDA) officials and other experts explored the challenges and opportunities surrounding real world evidence (RWE) in regulatory decision making.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Postmarket surveillance, Regulatory strategy

Tags: Real world evidence, RWE, Real world data, Janet Woodcock, Robert Temple, Sentinel

More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program By Zachary Brennan - Published 03 March 2016

In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics.

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

Tags: generic drugs, priority review voucher, Janet Woodcock, Susan Collins

FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II By Zachary Brennan - Published 28 January 2016

Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told Senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017.

Categories: News, US, CDER, Active pharmaceutical ingredients, Generic drugs, Due Diligence, Government affairs, Manufacturing, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: GDUFA, generic drugs, Janet Woodcock, Senate HELP, ANDA approvals

CDER’s Woodcock Outlines Priorities for 2016 By Zachary Brennan - Published 14 December 2015

With a banner year for new drug approvals under its belt in 2015 (42 approvals and counting), the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is now looking at how it can negotiate three new user fee agreements and fill an enormous number of staff vacancies this year.

Categories: News, US, CDER, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Manufacturing, Postmarket surveillance, Quality, Research and development

Tags: CDER, Janet Woodcock, FDA, drug development 2016, drug approvals

FDA's Woodcock to Senators: Need to First Get the Science Right on Biosimilars By Zachary Brennan - Published 17 September 2015

One of the most important parts of launching a robust US biosimilar market and setting up the regulations to support it is to make sure the scientific framework is "bulletproof," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators on Thursday.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, FDA, interchangeability, FDA guidance, Janet Woodcock, Zarxio

Another Reorganization for CDER: Its Office of Management By Alexander Gaffney, RAC - Published 15 January 2015

The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is already off to a busy start this year, having released new long-sought functions on its website, launched its new Office of Pharmaceutical Quality (OPQ) and hired a permanent director for its Office of Generic Drugs.

Categories: News, US, CDER

Tags: Office of Management, Janet Woodcock

FDA Launches New Drug Quality Office, With Goal of Improving the Pharmaceutical Industry By Alexander Gaffney, RAC - Published 13 January 2015

More than two years after first proposing the creation of a quality-focused office, the US Food and Drug Administration (FDA) has finally launched its new Office of Pharmaceutical Quality (OPQ) in a bid to standardize and centralize how drug quality is overseen by regulatory officials.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Manufacturing, Quality

Tags: OPQ, Office of Pharmaceutical Quality, Janet Woodcock

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

Woodcock to Legislators: FDA Has Limited Role to Play in Advancing Manufacturing By Alexander Gaffney, RF News Editor - Published 13 December 2013

Categories: US, FDA, Manufacturing

Tags: Janet Woodcock, Latest News, pharmaceutical, cGMP, drug

House Legislators Set to Grill FDA on FDASIA Progress By Alexander Gaffney, RF News Editor - Published 13 November 2013

Categories: US, FDA

Tags: FDASIA, Energy and Commerce Committee, Hearing, House, Janet Woodcock, Latest News, Jeffery Shuren

Woodcock: Reports of my Retirement Plans Greatly Exaggerated By Alexander Gaffney, RF News Editor - Published 11 October 2013

Categories: US, FDA

Tags: Woodcock, Janet Woodcock

Woodcock: FDA Strongly Supports Pharmaceutical Track and Trace By Alexander Gaffney, RF News Editor - Published 26 April 2013

Categories: US, FDA

Tags: Track and Trace, Janet Woodcock, Latest News, pharmaceutical, drug

FDA's Bob Temple Moving from ODE-1 to Other Position By Alexander Gaffney - Published 31 January 2012

Categories: FDA, CDER

Tags: Center for Clinical Science, Deputy Center Director, Ullis Unger, ODE-1, ODE, Bob Temple, Janet Woodcock, Latest News

Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify By Alexander Gaffney - Published 13 January 2012

Categories: FDA, CDER, CDRH

Tags: Margaret Hamburg, Testify, Hearing, Authorization, House, Law, Janet Woodcock, Reauthorization, MDUFA, Latest News, Jeffery Shuren, GDUFA, PDUFA

FDA Drug Approvals Up 42% in 2011, Regulatory Quality Highlighted By Alexander Gaffney - Published 05 January 2012

Categories: FDA, CDER

Tags: Janet Woodcock, Yervoy, Benlysta, Xarelto, Approvals, Latest News, NME, regulatory