Search Results for Califf

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Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market By Zachary Brennan - Published 15 August 2017

Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks of speeding new drugs and medical devices to market without enough preliminary evidence that they are effective.

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

Tags: surrogate measures, accelerated approval, high-risk devices, Rob Califf

Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky' By Zachary Brennan - Published 20 March 2017

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports

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

BIO Chair: Trump Should Re-Appoint Califf to Head FDA By Zachary Brennan - Published 17 November 2016

In a phone interview with Focus on Thursday, Ron Cohen, MD, president and CEO of Acorda Therapeutics and chair of industry group BIO, offered his views on increasing funding for the US National Institutes of Health (NIH), what the future may hold for the US Food and Drug Administration (FDA), as well as some new ideas and possible solutions to help contain rising drug prices.

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

Tags: Robert Califf, BIO, Acorda Therapeutics, CRISPR

FDA and Industry: How Dangerous is the Revolving Door? By Zachary Brennan - Published 16 November 2016

Earlier this week, a former deputy director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) settled charges that he provided tips on drug approvals to three hedge fund managers that made tens of millions off the non-public information.

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

Tags: industry and FDA, employees at FDA, Califf, Parexel, Sarepta, Greenleaf

Senators to FDA: Where are the Alternatives to Mylan’s EpiPen? By Zachary Brennan - Published 25 August 2016

Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector.

Categories: News, US, FDA, Combination products, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: EpiPen, Mylan, Robert Califf, Grassley, Klobuchar, Ron Johnson

Califf: Advances in Cardiology Will be Made by Integrating New Data Sources and Technologies By Michael Mezher - Published 09 August 2016

US Food and Drug Administration (FDA) Commissioner Robert Califf is calling on cardiologists to embrace new technologies and data sources, such as genetic sequencing, regenerative medicine, personal electronic devices and social media, in order to improve patient outcomes moving forward.

Categories: News, US, FDA, Clinical, Drugs, Regulatory strategy, Research and development

Tags: Cardiology, Robert Califf

FDA Commissioner Calls for Better National System to Track Device Safety By Zachary Brennan - Published 11 July 2016

The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Sentinel, device safety, NEST, GAO, Robert Califf

Regulatory Recon: Juno Halts Trial After 3 Deaths; Theranos CEO Banned From Running Lab for 2 Years (8 July 2016) By Zachary Brennan - Published 08 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, CFDA, EC, EMA, FDA, Health Canada, PMDA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance, Research and development

Tags: Juno, Theranos, Califf, FDA, Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

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

Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA By Michael Mezher - Published 11 May 2016

The "top programmatic priority" for the US Food and Drug Administration (FDA), under Commissioner Robert Califf, is to leverage real world evidence from the healthcare system to inform FDA decision making, he told participants at the Food and Drug Law Institute's annual conference last week.

Categories: News, US, FDA, Clinical, Drugs, Regulatory strategy, Submission and registration

Tags: Real world evidence, Sentinel, Robert Califf, FDLI

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

FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote By Zachary Brennan - Published 19 February 2016

Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday.

Categories: News, US, FDA, Compliance, Crisis management, Postmarket surveillance, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: opioids and FDA, Califf, Senate vote for Califf, Manchin, Markey, Bernie Sanders

Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising By Zachary Brennan - Published 16 February 2016

Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation.

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Drugs, Government affairs

Tags: Manchin, Markey, opioids, Califf, FDA, Valeant, AstraZeneca, Daiichi Sankyo

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

Califf Vows Not to Lower or Remove FDA Regulations By Zachary Brennan - Published 11 January 2016

President Barack Obama’s US Food and Drug Administration (FDA) commissioner nominee Robert Califf, who faces a Senate committee vote Tuesday, told legislators in written comments that he does not support the lowering or removal of regulations at FDA, though he previously said they were a barrier to innovation.

Categories: Biologics and biotechnology, Compliance, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices

Tags: Califf, FDA, quality metrics, foreign drug inspections, Lamar Alexander

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

What FDA Can and Can’t Do to Help Lower Rising Drug Prices By Zachary Brennan - Published 18 November 2015

Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview.

Categories: News, US, FDA, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: FDA, drug pricing, Robert Califf, Bernie Sanders, drug imports, ANDA backlog, generic drugs

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’s CDRH Unveils First-Ever Patient Engagement Advisory Committee By Zachary Brennan - Published 18 September 2015

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday announced the establishment of the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices.

Categories: News, US, CDRH

Tags: CDRH, patient engagement, advisory committee, PEAC, Robert Califf

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

FDA: What's Slowing Progress in Some Disease Areas? By Michael Mezher - Published 17 July 2015

In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy, Research and development

Tags: Precision Medicine, Biomarkers, Surrogate Endpoints, HCV, Alzheimer's, Robert Califf