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Ubl Gets Personal, Lays Out Vision for Future of PhRMA
PhRMA President and CEO Steve Ubl recently joined the Medium blogging website and penned his first post, "Health Care Veteran Gaines New Perspective." The post goes through the struggles his family experienced with chronic disease, and how they have shaped his approach to his role at PhRMA. This post is expected to be the first of many where he will dive into topics such as: PhRMA's policy solutions to deliver innovative treatments to patients, promise in the pipeline, and the biopharmaceutical industry's economic footprint, among many other issues.
Ubl opens his inaugural post by opening up about a phone call he receive...
Source: Policy and Medicine - July 28, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Unlikely Bedfellows: SEC Penalties When Industry Fails to Disclose FDA Recommendations for Clinical Trials
In a unique case, the U.S. Securities and Exchange Commission (SEC) recently announced a significant settlement with AVEO Pharmaceuticals for failing to disclose publicly as part of its quarterly financial filings that the FDA had recommended a second round of clinical trials for kidney cancer drug, Tivozanib, as part of the drug approval process. This case represents a new chapter in SEC regulatory oversight involving the life sciences industry when there are omissions, failure to disclose, and other transparency issues involving a company’s SEC filings.
On March 29, 2016, the SEC publicly announced fraud cha...
Source: Policy and Medicine - July 24, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Proposed Drug and Device Laws Should Be Pushed to 2017
By PAUL BROWN, TRACY RUPP, and STEVEN FINDLAY
Senate leaders now say they won’t consider companion legislation to the House-passed 21st Century Cures Act until September, after months of delay. Lawmakers would then have to reconcile the differing House and Senate versions, presumably by year’s end during a lame-duck Congress.
We believe the summer delay is a good thing, and that Congress should actually extend consideration of the complex legislation into 2017 when must-pass FDA funding through industry user-fees will be on the congressional calendar. That way, lawmakers can debate the implications of the propos...
Source: The Health Care Blog - July 14, 2016 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized 21st Century Cures Act Consumer's Union FDA User Fees Medical Devices Steven Findlay Source Type: blogs
Avalanche of New Cancer "Products" Will Confront the FDA
Cancer diagnosis and treatment is booming (see: What is cancer immunotherapy?) and the FDA is adapting to these changes with an organizational change. A recent article discussed a recent major organizational shift at the agency (see: Top Officials Aim To Reshape The FDA To Prepare For 'Avalanche' Of Cancer Products). Below is an excerpt from the article:
For 20 years, Richard Pazdur has run the office of the Food and Drug Administration charged with evaluating new cancer drugs, guiding the pharmaceutical industry as the business of oncology went from a relative backwater to the main event....[A]s part o...
Source: Lab Soft News - July 14, 2016 Category: Laboratory Medicine Authors: Bruce Friedman Source Type: blogs
Avalanche of New Cancer " Products " Will Confront the FDA
Cancer diagnosis and treatment is booming (see: What is cancer immunotherapy? ) and the FDA is adapting to these changes with an organizational change. A recent article discussed a recent major organizational shift & #0160;at the agency & #0160;(see: Top Officials Aim To Reshape The FDA To Prepare For & #39;Avalanche & #39; Of Cancer Products ). Below is an excerpt from the article: F or 20 years, Richard Pazdur has run the office of the Food and Drug Administration charged with evaluating new cancer drugs, guiding the pharmaceutical industry as the business of oncology went from a relative backwater to the main event.......
Source: Lab Soft News - July 14, 2016 Category: Laboratory Medicine Authors: Bruce Friedman Source Type: blogs
Limiting gay men donating blood: Discriminatory or rooted in science?
In the wake of the horrific Orlando shootings, there has been renewed attention given to the U.S. Food and Drug Administration’s (FDA) so-called ban on blood donations from gay men. A congressman called the ban discriminatory, and demanded it’s repeal — a call joined by the American Medical Student Association.
I can understand how many gay men feel. I often donated blood at various American Red Cross locations. Either they loved my blood or have way too many volunteers, because I was seemingly besieged with calls every eight weeks (the minimum waiting time between blood donations). Then in Februa...
Source: Kevin, M.D. - Medical Weblog - July 13, 2016 Category: Journals (General) Authors: Vamsi Aribindi Tags: Conditions Infectious disease Source Type: blogs
History Repeating – Is Insys a Warner Chilcott Clone?
This article outlines the arrests, how they are similar to previous arrests, and what can (and should) be done to stop activities like this from happening.
According to George Santayana, "those who fail to learn from history are doomed to repeat it". For the pharmaceutical industry, this appears to be true. Recently, the Department of Justice and the Federal Bureau of Investigation announced the arrest of two former employees of Insys Therapeutics for allegedly violating the Anti- Kickback Statute (AKS), as part of a scheme to pay doctors thousands of dollars to participate in sham educational programs. The purpose of th...
Source: Policy and Medicine - July 6, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Time To Fix The Black Hole In Medicare Data
Every year, the Medicare program pays for nearly 500,000 hip and knee replacement surgeries for America’s seniors. At the same time, approximately 25,000 patients undergo procedures to remove and replace a previous artificial joint, sometimes because it failed before the end of its expected useful life. Remarkably, and largely due to inadequacies in the systems that collect data through routine billing, the Medicare program is unable to identify product failures and patient safety problems, or to measure and promote high-value care with medical devices. This problem is serious, but can, and should, be fixed.
A number...
Source: Health Affairs Blog - June 29, 2016 Category: Health Management Authors: Ben Moscovitch, Josh Rising, Gregory Daniel and Joseph Drozda Tags: Costs and Spending Health IT Health Policy Lab Health Professionals Medicare Public Health Quality Alternative Payment Models Congress medical device safety medical devices unique device identifier Source Type: blogs
Four Ways To Address The Ethical Tensions Around Expedited Approval Of New Prescription Drugs
The Food and Drug Administration (FDA) requires a new drug’s manufacturer to present affirmative evidence of its efficacy and safety before it can be marketed. Because testing new drugs requires a delay between identification of an important, novel prescription drug and FDA approval, some patients with serious or life-threatening illnesses and no satisfactory options will not live to see a potentially life-saving medication approved for public use.
To address this concern, the FDA and Congress have established several programs—with the support of pharmaceutical manufacturers and some patient advocacy groups—t...
Source: Health Affairs Blog - June 23, 2016 Category: Health Management Authors: Aaron Kesselheim, Spencer Phillips Hey, Dalia Deak and Bernard Lo Tags: Drugs and Medical Technology Featured Population Health Public Health Quality Bioethics breakthrough drugs Drug approval FDA priority review Risk Evaluation and Mitigation Strategies Source Type: blogs
PhRMA Members Invested $58.8 Billion in R&D in 2015
In 2015, PhRMA member companies invested $58.8 billion in research and development, up 10.3% from 2014. The new R&D data is based on findings from the 2016 PhRMA annual member survey released in the 2016 Biopharmaceutical Research Industry Profile and the corresponding industry chart pack, Biopharmaceuticals in Perspective, which highlighted the wide-reaching impact of PhRMA member companies on the economy and biopharmaceutical innovation.
In the United States, the biopharmaceutical industry is a driver of economic growth and global competitiveness, and is the most research-intensive sector of the economy. The biopharmac...
Source: Policy and Medicine - June 16, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
How Patient Groups Have Begun To Influence The Value And Coverage Debate
In 2015, two issues related to medicine could be relied on to generate headlines: drug pricing and the proliferation of new value frameworks that claimed to define the value and even the price of drugs in seemingly easy-to-understand ways. In none of the high-profile skirmishes on pricing or frameworks was the voice or perspective of patients and patient groups very much in evidence. But that is beginning to change, in an evolution of a broader shift in the role that patients are playing in the research and development (R&D) enterprise.
A New Culture of Engagement
Patients and patient organizations are becoming ever mo...
Source: Health Affairs Blog - June 10, 2016 Category: Health Management Authors: Margaret Anderson and Kristin Schneeman Tags: Costs and Spending Health Professionals Organization and Delivery Quality clinical research patient use of evidence venture philanthropy Source Type: blogs
DOJ Announces Genentech and OSI Pharmaceuticals, LLC Settlement
The Department of Justice (DOJ) has announced that pharmaceutical companies Genentech and OSI Pharmaceuticals, LLC, will pay $67 million to resolve allegations that they made misleading statements about the effectiveness of the drug Tarceva to treat lung cancer.
This settlement resolves allegations "that between January 2006 and December 2011, Genentech OSI Pharmaceuticals made misleading representations to physicians and other health care providers about the effectiveness of Tarceva to treat certain patients with non-small cell lung cancer, when there was little evidence to show that Tarceva was effective to treat those...
Source: Policy and Medicine - June 6, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Patient-Driven Research Will Lead To Better Health
The role of patients in health research is changing dramatically. Once considered simply study “subjects,” today patients play a meaningful and critical role in research. Such involvement ensures study results are more useful to them as well as others involved in making important health care decisions.
Patients bring issues that matter to them—such as quality of life and ability to function—to the forefront of conversations about how to evaluate the effectiveness of health care options. They are working alongside scientists as partners in designing and conducting research and are key to the successful disse...
Source: Health Affairs Blog - May 19, 2016 Category: Health Management Authors: Grayson Norquist Tags: Featured Health Professionals Hospitals Population Health Quality 21st Century Cures Act FDA patient use of evidence patient-centered outcomes research PCORI Source Type: blogs
Is High Prescription Drug Spending Becoming Our New Normal?
This report concluded there was value in these therapies but also raised concerns about whether their effects will translate into lower rates of heart attack and stroke. Further, ICER concluded that a discount of 67 percent off the drugs’ list price would better represent their overall benefit. ICER’s assessment is still in draft form and it remains unclear whether the report will have any effect. Nevertheless, such work is a step in the right direction.
Other entities are developing alternative methods to evaluate prescription drugs. The American Society for Clinical Oncology has sought comment on its proposed val...
Source: Health Affairs Blog - May 17, 2016 Category: Health Management Authors: Leigh Purvis and Crystal Kuntz Tags: Costs and Spending Drugs and Medical Technology Featured Payment Policy Quality Big Pharma Biosimiliar Comparative Effectiveness FDA PCSK9 inhibitors Sovaldi specialty drugs Source Type: blogs
We Need To Fill The Gap Between What We Know And Don’t Know About E-cigarettes
Cigarettes. Roll-your-own tobacco. Smokeless tobacco. Cigars. Cigarillos. Pipe tobacco. Electronic cigarettes. Gels. Water pipes. The evolution of nicotine delivery systems has raised as many new questions for public health as it has brought new products to market. But none is more controversial than e-cigarettes.
The ongoing debate over the public health implications of e-cigarette use is full of passion. Some argue that e-cigarettes could be the beginning of the end of smoking in the U.S. Others claim e-cigarettes may erase the hard-won progress achieved over the last half-century in reducing nicotine and tobacco addicti...
Source: Health Affairs Blog - May 5, 2016 Category: Health Management Authors: Sudip Parikh Tags: Drugs and Medical Technology Featured Public Health Quality e-cigarettes FDA smoking cessation Tobacco Control Act Source Type: blogs
