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Total 341 results found since Jan 2013.
Patient Informed Consent from Partially Uninformed Physicians
The title of this thread clearly sets the topic to be discussed. Informed consent by a patient for an examination or medical-surgical procedure is an established ethical and legal act which has been even more focused throughout the medical profession in the recent decades when previous professional paternalism behavior dissolved to patient autonomy. However established the practice is preached, the act still depends on several factors. With regard to the patient becoming informed about the details of the examination and procedure, it requires the patient or patient's surrogate making a decision to comprehend wh...
Source: Bioethics Discussion Blog - March 6, 2014 Category: Health Medicine and Bioethics Commentators Source Type: blogs
The Safety of Diabetes Drugs
A possible connection between one of our newest and most important classes of diabetes drugs and pancreatic cancer has frightened many of us. But people with diabetes can now breathe easier.
The United States Food and Drug Administration and its European counterpart just released their joint findings concluding that these drugs, which include Byetta, Victoza, Bydureon, and Januvia, have “no compelling evidence of an increased...
Source: David Mendosa's SharePosts - March 5, 2014 Category: Diabetes Authors: David Mendosa Source Type: blogs
As Full Disclosure Nears, Doctors’ Pay for Drug Talks Plummets
Some of the nation’s largest pharmaceutical companies have slashed payments to health professionals for promotional speeches amid heightened public scrutiny of such spending, a new ProPublica analysis shows.Eli Lilly and Co.’s payments to speakers dropped by 55 percent, from $47.9 million in 2011 to $21.6 million in 2012.Pfizer’s speaking payments fell 62 percent over the same period, from nearly $22 million to $8.3 million.And Novartis, the largest U.S. drug maker as measured by 2012 sales, spent 40 percent less on speakers that year than it did between October 2010 and September 2011, reducing payments from $24.8 m...
Source: PharmaGossip - March 4, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
FDA Draft Guidance Analgesic Indications: Developing Drug and Biological Products
The FDA recently released a new draft guidance with recommendations on how sponsors of analgesic painkillers should develop products in preparation for future marketing authorization. The draft, "Analgesic Indications: Developing Drug and Biological Products", is intended for sponsors of analgesic products intended to treat acute, chronic and breakthrough pain.
All three types of pain—acute, chronic and breakthrough—are characterized by the need for long-term, regular treatment with analgesics. FDA notes that while it is important to understand how a single dose of the drug works, it's even more interested in underst...
Source: Policy and Medicine - February 27, 2014 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Pharma companies shouldn't conduct clinical trials: Peter C Gøtzsche
Allowing pharmaceutical companies to conduct drug trials is the equivalent of a defendant alone presenting all the evidence to determine whether he is guilty or not, argues Peter C Gøtzsche, co-founder of The Cochrane Collaboration, a global independent network of health practitioners, researchers, patient advocates and others, and author of the recently released Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare. In a candid email interview withIndulekha Aravind, Denmark-based Gøtzsche, who is a specialist in internal medicine and has also worked with clinical trials and regulatory a...
Source: PharmaGossip - February 16, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
E-cigarettes: A Fork in the Road
E-cigarettes are a new, increasingly popular product that provides a different method for use of nicotine. American smokers have increased buying of e-cigarettes at a record pace and annual sales for 2013 were expected to reach $1.7 billion. But there are many questions about e-cigarettes: What exactly is in e-cigarettes? How harmful are they to smokers? How harmful are the second-hand vapors? Who will set the rules and standards for the products?
Many of these questions are not yet answered and that has caused concerns to consumers, regulators, and the public. The debate over e-cigarettes is akin to the debates that o...
Source: Disruptive Women in Health Care - January 27, 2014 Category: Health Medicine and Bioethics Commentators Authors: dw at disruptivewomen.net Tags: Cancer Consumer Health Care Source Type: blogs
Breast Imaging Cuts in Medicare Final Rule May Delay Diagnosis and Treatment and Increase Patient Anxiety
Washington, DC (Nov. 27, 2013) — Drastic reimbursement cuts for image-guided breast biopsies and other medical imaging techniques in the 2014 Medicare Fee Schedule Final Rule may further reduce women’s access to mammography and other breast cancer services. The Centers for Medicare and Medicaid Services (CMS) directly cut imaging reimbursement every year since 2007. This, along with 12 Medicare imaging cuts in the last six years due to legislation, increasingly threatens patient care.
Repeated imaging cuts have reduced funding for many common exams up to 50 percent. This is forcing many facilities to close or cut servi...
Source: radRounds - November 30, 2013 Category: Radiologists Authors: radRounds Radiology Network Source Type: blogs
23 And Me And the FDA
As everyone will have heard the personal-genomics company 23 and Me was told by the FDA to immediately stop selling their product, a direct-to-consumer DNA sequence readout. Reaction to this has been all over the map. I'll pick a couple of the viewpoints to give you the idea.
From one direction, here's Matthew Herper's article, with the excellent title "23 And Stupid". Here's his intro, which makes his case well:
I’d like to be able to start here by railing against our medical system, which prevents patients from getting data about our own bodies because of a paternalistic idea that people can’t look at blood test re...
Source: In the Pipeline - November 27, 2013 Category: Chemists Tags: Regulatory Affairs Source Type: blogs
FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit
The Food and Drug Administration (FDA) sent a WARNING letter to the CEO of 23andMe because the company is illegally marketing its 23andMe Saliva Collection Kit and Personal Genome Service (PGS). "This product," says FDA, "is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." Recall that Genentech teemed up with 23andMe -- a personal genetics firm -- to collect spit...
Source: Pharma Marketing Blog - November 25, 2013 Category: Pharma Commentators Tags: 23andMe Avastin Genentech warning letter Source Type: blogs
On World Diabetes Day, A Tribute to Mary Hunt
The diabetes community lost another member recently. I knew her as Mary Hunt, and she died at age 66. She had been hospitalized for illness recently, so her passing was not a complete surprise to her family, but its always sad when we lose someone of any age. Her husband Dave shared the news via email the other day. In many ways, Mary was one of the developers of today's Diabetes Online Community. She helped start the Diabetics International Foundation [http://members.tripod.com/diabetics_world/], which worked tirelessly for the many patients who suffered hypoglycemia unawareness attributed to...
Source: Scott's Web Log - November 14, 2013 Category: Diabetes Tags: 2013 Insulin Dependent Diabetes Trust Mary Hunt Mary Sebastian-Hunt Source Type: blogs
On World Diabetes, A Tribute to Mary Hunt
The diabetes community lost another member recently. I knew her as Mary Hunt, and she died at age 66. She had been hospitalized for illness recently, so her passing was not a complete surprise to her family, but its always sad when we lose someone of any age. Her husband Dave shared the news via email the other day. In many ways, Mary was one of the developers of today's Diabetes Online Community. She helped start the Diabetics International Foundation [http://members.tripod.com/diabetics_world/], which worked tirelessly for the many patients who suffered hypoglycemia unawareness attributed to...
Source: Scott's Web Log - November 14, 2013 Category: Diabetes Authors: Scott S Source Type: blogs
Orphan Drugs - The Seattle Times explains
The mining of rare diseasesThirty years ago, Congress acted to spur research on rare diseases. Today, we have hundreds of new drugs — along with runaway pricing and market manipulation, as drugmakers turn a law with good intentions into a profit engine.By Michael J. Berens and Ken ArmstrongHer vision failed first.Then she fell asleep at school from inexplicable fatigue. Even walking proved difficult, often impossible, as she knocked into furniture and walls. It was like an electrical switch in her body toggled without warning. Some days she was in control, most she was not.Specialists were s...
Source: PharmaGossip - November 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Ranbaxy whistleblower reveals how he exposed massive pharmaceutical fraud
(CBS News) Among the drugs prescribed to Americans, 80 percent are generic drugs, and 40 percent of drugs are now made overseas in countries such as China and India where U.S. oversight is weaker.
Recently, CBS News' senior correspondent John Millerhas been looking at one of those companies -- Ranbaxy.
Dinesh Thakur, an American-educated chemical engineer, was hired by Ranbaxy, back in 2003. He would later become a whistleblower, exposing massive fraud by the generic pharmaceutical giant, a company that sold Americans drugs like the generic version of Lipitor. His information led to Ranbaxy pleading guilty to seven f...
Source: PharmaGossip - November 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
F.D.A. Urging a Tighter Rein on Painkillers - NYTimes.com
The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers, changes that are expected to take place as early as next year.The move, which represents a major policy shift, follows a decade-long debate over whether the widely abused drugs, which contain the narcotic hydrocodone, should be controlled as tightly as more powerful painkillers like OxyContin.The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lo...
Source: Psychology of Pain - October 25, 2013 Category: Psychiatrists and Psychologists Source Type: blogs
Former FDA Commissioner, CMS Administrator McClellan adds Johnson and Johnson Board Membership to Positions with General Atlantic LLC, Capital Royalty, Castlight Health, and AvivReit
Our latest example of the interchangeability of top insiders within corporate health care and the government agencies that are supposed to regulate corporate health care comes via an announcement from Johnson and Johnson,Johnson & Johnson (NYSE: JNJ) announced today that Mark B. McClellan, M.D., Ph.D., Senior Fellow in Economic Studies, and Director of the Initiative on Value and Innovation in Health Care, Brookings Institution, will join the Board of Directors on October 15, 2013. Dr. McClellan will serve on the Regulatory, Compliance & Government Affairs Committee and the Science, Technology & Sustainab...
Source: Health Care Renewal - October 18, 2013 Category: Health Medicine and Bioethics Commentators Tags: CMS corporatism DHHS FDA Johnson and Johnson revolving doors Source Type: blogs
