Search Results for Commissioner

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Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence By Zachary Brousseau - Published 28 September 2017

Watch FDA Commissioner Scott Gottlieb's keynote address to attendees of RAPS’ 2017 Regulatory Convergence, focusing on making the clinical end of drug development more efficient and effective.

Tags: FDA, Commissioner, Scott Gottlieb, Regulatory Convergence, drug development, clinical trials, adaptive clinical trials, seamless clinical trials

Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies By Zachary Brennan - Published 11 September 2017

FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Scott Gottlieb, FDA commissioner, clinical development

UPDATE: FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence By Zachary Brousseau - Published 23 August 2017

FDA Commissioner Scott Gottlieb will address the global regulatory community on 11 September, delivering keynote remarks at the 2017 Regulatory Convergence conference at National Harbor on the DC Waterfront.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: FDA, commissioner, Gottlieb, Regulatory Convergence, keynote

Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse By Zachary Brennan - Published 16 May 2017

Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse."

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

Tags: Scott Gottlieb, FDA commissioner, opioids, 21st Century Cures

10 Hot-Button Issues FDA’s New Commissioner Will Face By Zachary Brennan - Published 11 May 2017

Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency.

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

Tags: Scott Gottlieb, FDA commissioner, LDTs, Cures, opioids, off-label marketing, regulatory convergence

Senate Confirms Gottlieb as Next FDA Commissioner By Zachary Brennan - Published 09 May 2017

The Senate on Tuesday afternoon voted along party lines to confirm Dr. Scott Gottlieb as the next US Food and Drug Administration (FDA) commissioner.

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

Tags: Scott Gottlieb, FDA commissioner, new FDA commissioner

Senate Committee Advances Gottlieb Nomination as FDA Commissioner By Zachary Brennan - Published 27 April 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA).

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

Tags: Gottlieb, Senate FDA, FDA commissioner

Senate HELP Committee Delays Vote on Gottlieb Nomination By Michael Mezher - Published 26 April 2017

Senate HELP Committee Chairman Lamar Alexander (R-TN) on Wednesday delayed an expected vote on Scott Gottlieb's nomination to head the US Food and Drug Administration (FDA).

Categories: News, US, FDA

Tags: Scott Gottlieb, Nomination, FDA Commissioner, Senate HELP Committee

FDA Commissioner Nominee Faces Limited Opposition From Senate Committee By Zachary Brennan - Published 05 April 2017

The Senate Health, Labor, Education & Pensions Committee on Wednesday offered praise and only a few muted attacks against Scott Gottlieb, President Donald Trump's nominee to be the next commissioner of the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Business and Leadership, Government affairs

Tags: Scott Gottlieb, FDA commissioner, Senate HELP hearing

Trump Taps Scott Gottlieb to Head FDA By Zachary Brennan - Published 10 March 2017

Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute (AEI) and former US Food and Drug Administration (FDA) official, has been selected by President Donald Trump to lead FDA as commissioner. The White House confirmed the appointment on Friday and Gottlieb will face a Senate hearing and vote.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Scott Gottlieb, Trump FDA, FDA commissioner

Trump’s FDA Commissioner Choice Coming Soon By Zachary Brennan - Published 08 March 2017

Dr. Tom Price, secretary of the US Department of Health and Human Services, said in an interview this week that the new commissioner for the US Food and Drug Administration (FDA) and other health-related political appointees should be announced in the next week or so.

Categories: News, US, FDA, Due Diligence, Government affairs

Tags: FDA commissioner, Scott Gottlieb, Tom Price

Potential Trump FDA Commissioner Choice: A Q&A With Dr. Joseph Gulfo By Zachary Brennan - Published 24 January 2017

A potential President Donald Trump choice for US Food and Drug Administration (FDA) commissioner spoke with Focus on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence

Tags: FDA commissioner, Gulfo, Trump and FDA

Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees By Zachary Brennan - Published 20 January 2017

Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Rob Califf, FDA commissioner, benefit-risk assessments, pharmaceuticals, medical devices

Politicizing the FDA: What the Trump Win Means for New Pharma Regulations By Zachary Brennan - Published 19 January 2017

President-Elect Donald Trump on Friday will become the 45th US president and though he’s yet to name his choice for commissioner of the US Food and Drug Administration (FDA), the names of those floated to lead the agency and a recent flood of new draft and finalized FDA guidance reveal an agency bracing for change.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Trump, FDA, FDA commissioner pick, Rob Califf

FDA Commissioner Listed in CMS Database for Receiving Payments from GSK, AstraZeneca in 2015 By Zachary Brennan - Published 01 July 2016

In what might turn out to be an odd mistake, the current US Food and Drug Administration (FDA) Commissioner Rob Califf was included in a database of pharmaceutical company payments to physicians updated by the US Centers for Medicare & Medicaid Services (CMS) on Thursday.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Robert Califf, FDA commissioner, industry payments to FDA

2015 Regulatory Convergence Highlights: Stephen Ostroff's Keynote By Zachary Brousseau - Published 23 June 2016

Each year, the Regulatory Convergence features dozens of speakers and panelists representing global regulatory agencies, including FDA and many others. Among the highlights of the 2015 Convergence in Baltimore was the opportunity to hear a keynote address from then-Acting FDA Commissioner Stephen Ostroff.

Categories: HTML, Video, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, 2015, FDA, Ostroff, FDA Commissioner

New Report Calls on FDA to Clarify Use of Real-World Evidence By Zachary Brennan - Published 23 June 2016

As legislation to speed the process by which the US Food and Drug Administration (FDA) approves new drugs and devices continues to stall in Congress, mostly because of disagreement over funding for the National Institutes of Health (NIH) and patient safety concerns, a nonprofit on Thursday released a new report calling for FDA to clarify ways real-world evidence can be used to support clinical trials and postmarket commitments.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Product withdrawl and retirement

Tags: real world evidence, FDA Commissioner, Robert Califf, Patrick Soon-Shiong, Duke University

Senate Confirms Califf as Next FDA Commissioner By Michael Mezher - Published 24 February 2016

The US Senate on Tuesday voted 89 to 4 to confirm Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA).

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

Tags: Dr. Robert Califf, FDA Commissioner, Confirmation, Nomination

Updated: Califf Headed for Confirmation as Next FDA Commissioner By Zachary Brennan - Published 23 February 2016

Only six senators voted against Robert Califf in a procedural vote late Monday, setting up a final vote for his appointment as the next commissioner of the US Food and Drug Administration. On Tuesday, a handful of senators continued to criticize FDA over opioid approvals.

Categories: News, US, FDA, Clinical, Drugs, Government affairs

Tags: Califf, FDA commissioner, FDA officials

Senate HELP Committee Votes in Favor of Califf for FDA Commissioner By Zachary Brennan - Published 12 January 2016

The US Senate Committee on Health, Education Labor & Pensions (HELP) on Tuesday voted in favor of letting the full Senate vote to approve Robert Califf as the next Food and Drug Administration (FDA) commissioner.

Categories: News, US, FDA, Government affairs

Tags: Califf, FDA commissioner, Senate HELP

EMA Investigating Validity of Clinical Trial Led by FDA Commissioner Nominee By Zachary Brennan - Published 03 December 2015

The European Medicines Agency (EMA) has told Focus that it’s currently investigating whether a medical device defect may have had an impact on a major clinical trial that was designed and overseen by FDA commissioner nominee Robert Califf and ultimately led to the drug’s FDA and EMA approvals.

Categories: News, Europe, US, EMA, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Research and development

Tags: EMA, Califf, FDA, FDA commissioner, Xarelto, Bayer

Senators Hint at Confirmation of Califf as Next FDA Commissioner By Zachary Brennan - Published 17 November 2015

Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Clinical, Combination products, Drugs, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Califf, Senate HELP, FDA commissioner, Senate confirmation hearing, Duke University, Margaret Hamburg, Elizabeth Warren, Bernie Sanders

FDA Commissioner Outlines Critical Time Ahead for Agency By Zachary Brennan - Published 27 October 2015

As the US Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for new major legislation overhauling parts of its operations, a major transformation is in the works over the next couple of years.

Categories: News, US, FDA, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA, Ostroff, FDA Commissioner, user fees, AdvaMed

President Obama Nominates Califf as Next FDA Commissioner By Zachary Brennan - Published 15 September 2015

President Barack Obama has nominated Robert Califf, the current deputy commissioner for medical products and tobacco at the US Food and Drug Administration (FDA), as the next commissioner of the agency.

Categories: News, US, FDA, Combination products, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Robert Califf, FDA, Margaret Hamburg, FDA Commissioner

Acting FDA Commissioner Stephen Ostroff to Speak at RAPS' Regulatory Convergence By Zachary Brousseau - Published 18 June 2015

Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff, MD, will speak to attendees of the 2015 RAPS Regulatory Convergence. RAPS’ signature annual event for the regulatory profession will take place 24–28 October in Baltimore.

Categories: HTML, Articles, Under RAPS, RAPS Events, US, FDA, RAPS

Tags: 2015 RAPS, Regulatory Convergence, Stephen Ostroff, Ostroff, FDA commissioner, acting FDA commissioner, FDA, US Food and Drug Administration, keynote, plenary, Baltimore, conference