October 16, 2014. We strongly urge you to urge the FDA to keep the black box warning to protect patients and that you strengthen rather than weaken that boxed warning. And, since the meta analyses are fatally flawed, as I and others have pointed out, the FDA should delete the misleading meta-analyses info from the Chantix label. Continue reading
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Statement of Diana Zuckerman, PhD at FDA Joint Public Advisory Committee Meeting on Chantix
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Comments on Internet/Social Media Platforms Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
October 29, 2014. We welcome the opportunity to provide feedback on this draft guidance regarding use of internet and social media platforms for communicating about medical products. Patients and consumers increasingly rely on social media and the internet as sources of health and medical information that influence their decisions to seek medical care. Continue reading
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Testimony of Dr. Laurén Doamekpor Before the FDA Risk Communication Advisory Committee on fish consumption
November 3, 2014 Good afternoon. My name is Dr. Laurén Doamekpor, and I am a senior fellow at the National Center for Health Research. Our non-profit research center is dedicated to improving the health and safety of adults and children … Continue reading
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Cushing’s Syndrome: A Tale of Frequent Misdiagnosis
Cushing’s syndrome occurs when the tissues of the body are exposed to high levels of cortisol for an extended amount of time. The symptoms seem distinctive, yet it is often difficult for those with Cushing’s syndrome to get an accurate diagnosis. Read about this frequently misdiagnosed disease! Continue reading
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Testimony of Dr. Anna Mazzucco Before the FDA Advisory Committee on Anti-Infective Drugs
December 5, 2014. We are all concerned about the growing problem of antibiotic resistance. We want to ensure effective treatment options for those with serious infections. However, ineffective antibiotics actually worsen our situation by increasing antibiotic resistance. Continue reading
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Testimony of Dr. Laurén Doamekpor Before the FDA Risk Communication Advisory Committee on fish consumption
November 3, 2014 Good afternoon. My name is Dr. Laurén Doamekpor, and I am a senior fellow at the National Center for Health Research. Our non-profit research center is dedicated to improving the health and safety of adults and children … Continue reading
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Statement of Anna E. Mazzucco, Ph.D. Before the Food and Drug Administration on Updating the “Redbook”
December 9, 2014. We enthusiastically welcome further action from the FDA on all substances over which the Center for Food Safety and Applied Nutrition has authority. While the FDA has taken steps to address safety concerns regarding some substances, we strongly urge the agency to use its full authority to ensure the safety of all food-related and consumer products. Continue reading
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Testimony of Dr. Christina Silcox Before the FDA Blood Products Advisory Committee
December 3, 2014. The FDA’s regulation of blood establishment computer software (BECS) and BECS accessories has enhanced the safety of blood transfusion. In the 90’s the FDA found numerous problems with BECS software, including the potential release of infectious blood. … Continue reading
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Testimony of Dr. Margaret Dayhoff-Brannigan Before the FDA Advisory Committee on Anti-Infective Drugs
December 4, 2014. Antibiotic resistance and the inability to treat common infections is an increasingly urgent public health crisis which affects everyone, especially some of the most vulnerable in our society. Finding treatment options for unmet populations is urgently important but ineffective antibiotics lead to an increase in antibiotic resistance. Continue reading
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Preventing and Treating Alzheimer’s and Dementia
Exercise was shown to protect against the brain shrinking even if people with a family history of Alzheimer’s disease. Continue reading
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Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers
December 15, 2014. We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. The Cardiovascular Devices Panel stated on March 9, 1979 that these devices should be classified into Class III because the device “provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.” Continue reading
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Comments on the proposed order on Reclassification of Iontophoresis Devices Intended for Any Other Purposes
December 22, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on the proposed order on Reclassification of Iontophoresis Devices … Continue reading
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Letters to Senate Leadership Supporting the Medical Device Excise Tax
To view as a PDF, click here. June 4, 2014 The Honorable Harry Reid Majority Leader United States Senate Washington, DC 20510 Dear Majority Leader Reid, As members of the Patient, Consumer, and Public Health Coalition, we thank you for … Continue reading
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Testimony of Dr. Anna Mazzucco before the FDA on “Framework for Regulatory Oversight of Laboratory Developed Tests”
Our Center has frequently urged the FDA to improve their oversight of medical devices. Despite past criticisms, we believe it is essential that FDA have the authority to regulate laboratory-developed tests in order to stimulate even better science, and help ensure that patients receive the full benefit of our growing scientific knowledge. Continue reading
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Letter to FDA Commissioner Hamburg on New Antibiotic Product (CAZ-AVI)
December 19, 2014. We are writing to express our strong concerns about the approval standards considered and the conflicts of interest apparent at the December 5, 2014 FDA meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) regarding a new combination antibiotic product, ceftazidime-avibactam (CAZ-AVI). Continue reading
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Quitting Smoking: Women and Men May Do It Differently
By Anna E. Mazzucco, PH.D. December 27, 2013 Quitting smoking is hard to do, and new studies suggest that what works for men may not always work for women, and vice versa. Scientists believe that nicotine is more important … Continue reading
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Congress is Up to Something
January 23 Update After this blog was written, Sen. Orrin Hatch (R-UT) introduced S. 160, which would repeal the tax described below. No need to look at the facts – just bow to special interests while trying to kill Obamacare! … Continue reading
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House GOP proposes changes for NIH, FDA
The Baltimore Sun: House Republicans are considering significant changes to the way billions of dollars in National Institutes of Health grants are awarded to research institutions under a proposal intended to speed medical breakthroughs. Continue reading
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Comments on the proposed order on Reclassification of Iontophoresis Devices Intended for Any Other Purposes
December 22, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of members of the Patient, Consumer, and Public Health Coalition on the proposed order on Reclassification of Iontophoresis Devices … Continue reading
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Letters to Congressional Leadership Supporting the Medical Device Excise Tax
This is a sample of the letters that were sent to key Democrats and Republicans in the House and Senate in January 2015. To view this sample letter as a PDF, click here. To view a sample of an earlier version … Continue reading
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