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Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA committee on Vaccines and Related Biological Products

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March 4, 2015. An effective flu vaccine is critical for public health. Antiviral medications have very limited efficacy, so for many people the flu vaccine is the best line of defense to protect against infection. The CDC’s latest report calculated a 19% vaccine efficacy this year. That is simply not good enough. More importantly, this is not just one bad year. Four of the last 10 years the vaccine has been less than 40% effective. Continue reading

Analysis of Impact of Device Excise Tax on U.S.-Based Medical Device Companies

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Download the PDF of the most recent NCHR Analysis of Impact of Device Excise Tax. Is the Medical Device Tax Fair? Does it Harm Companies? The purpose of the 2.3% excise tax on medical devices, which was implemented in January … Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA committee on Dermatologic and Ophthalmic Drugs on clinical trials for Atopic Dermatitis in pediatric patients

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March 9, 2015. Atopic dermatitis affects a very young patient population, so it critical to have safety information for all age groups to prevent dangerous off label use. This is a vulnerable patient population, and the benefits for the treatment must be proven to outweigh the risks. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan before the FDA Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee discussing a new drug application for Asthma

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March 19, 2015. Long-acting beta-agonists have a history of serious adverse events in asthma patients including a four-fold increase in asthma-related death. So, let’s start with the assumption that we don’t want a new LABA on the market unless we have good evidence about safety and efficacy. Continue reading

Comments on Transfer of Premarket Notification Clearance

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We support the draft guidance with one suggested revision to Section V to help in clarifying who currently holds a 510(k) device. Overall, this guidance will help to ensure that the public information in the FDA’s 510(k) databases are accurate and up-to-date, including the most current owner of a 510(k) device. Continue reading

Will 20th Century Patient Safeguards be Reversed in the 21st Century?

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The BMJ, March 25, 2015. Our new commentary warns of potentially deadly consequences of new legislation to speed the drug approval process while weakening the standards for safety and efficacy. Continue reading

Are We Asking the Wrong Questions about Campus Sexual Assault?

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Rodale.com, March 10, 2015. This year, 173 people in the U.S. came down with the measles, and that is being treated as an epidemic requiring urgent action. Surely, campus rape deserves at least as much public health attention. Continue reading

2015 Foremother and Health Policy Hero Awards Luncheon

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The National Center for Health Research Cordially Invites You to Our 2015 Foremother and Health Policy Hero Awards Luncheon Friday, May 8, 2015 at Noon  The Cosmos Club of Washington, D.C. 2121 Massachusetts Ave NW Please join us and WJLA’s Maureen Bunyan on May 8th, … Continue reading

Testimony on Generic Drug Labeling before FDA by Anna E. Mazzucco, Ph.D.

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March 27, 2015. The current situation creates a terrible double standard, making patient with generic drugs second class citizens. And, when brand name drug manufacturers leave the market after generics become available, nobody is held responsible for updating the label. This is completely unacceptable. Continue reading

What You Can Do to Improve Your Sleep and Your Health

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Many children and adults are not getting enough sleep. There are always good excuses – Too much work to do! I just got an email or text message that I need to respond to! – but the bottom line is you need more sleep and it’s much better to find ways to fall asleep naturally than to rely on sleeping pills. Continue reading

Essure Permanent Contraception Device: Not so Permanent and Many Side Effects

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Accurate information about how well Essure works and its long-term safety are essential so that women who do not want more children can make an informed choice regarding their contraceptive options. Continue reading

Benadryl and Other Common Medications Are Linked to Dementia in Men and Women

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Many people turn to over-the-counter medicines when they need relief from allergy and cold symptoms or have trouble falling asleep. That’s why you might be concerned about a new study showing that one of the most common of those drugs—Benadryl—could lead to serious health problems, including dementia. Continue reading

Women share concerns about permanent birth control device with FDA

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WJLA-TV (ABC NEWS), April 2, 2015. NCHR president Dr. Zuckerman accompanied women harmed by Essure permanent birth control to meet with FDA officials. They told FDA that women in terrible pain from Essure got no help from their doctors and then were dumped from the company’s clinical trials. This made the study results look better so that Essure would be approved. Continue reading

To Tamiflu or not to Tamiflu?

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The flu is hitting hard and you may have friends and family that are getting sick. Here is the information you need to know about current treatment options for the flu. Continue reading

What you need to know about the measles and vaccines

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Measles is in the news, and many parents are wondering if their children are at risk. Here is what you need to know. Continue reading

What Do Stakeholders Think Of FDA’s Latest Effort To Get Patients Timelier Access To Devices?

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The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs...Not everyone is pleased with the guidance, however. Continue reading

Diet Drug Companies Spent $60 Million Since 2010 Amid Push to Win FDA Approval for New Products

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In the months before the U.S. Food and Drug Administration did an about-face on diet drugs, agency officials participated in a series of meetings at George Washington University. Continue reading

Bill to Speed Approvals for Drugs Is Cut Back

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By Sabrina Tavernise, New York Times April 30, 2015 WASHINGTON — Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version … Continue reading

Long-Term Data on Complications Adds to Criticism of Contraceptive Implant

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When a new contraceptive implant came on the market over a decade ago, it was considered a breakthrough for women who did not want to have more children, a sterilization procedure that could be done in a doctor’s office in just 10 minutes. Continue reading

National Center for Health Research Honors 2015 Foremothers and Health Policy Heroes at Cosmos Club on Friday

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Two trailblazing women and a courageous physician couple will be honored by the National Center for Health Research at its 11th annual luncheon at the Cosmos Club on May 8, the Friday before Mother’s Day. Continue reading
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