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I-Team: Company Behind EpiPen Fought to Keep Cheaper Generic off Market
Chris Glorioso and Evan Stulberger, NBC4 New York August 31, 2016 The CEO of Mylan Pharmaceuticals announced the launch of its own cheaper version of the EpiPen this week on the heels of a price hike uproar. But for years, Mylan and its business partners have fought fiercely behind the scenes to block a cheaper generic from… Continue reading I-Team: Company Behind EpiPen Fought to Keep Cheaper Generic off Market
D.C. Week: NOAC Reversal Drug Stalls at FDA
Shannon Firth, MedPage Today August 20, 2016 […] PDUFA Again: Still Trying to Get It Right Industry and patient representatives embraced the sixth version of the Prescription Drug User Fee Act, aka PDUFA, while consumer groups balked at the unabashed enthusiasm shown by their counterparts at a public meeting held by the FDA on Monday. As Marc… Continue reading D.C. Week: NOAC Reversal Drug Stalls at FDA
Part D pricing trends
Sarah Karlin-Smith and Brett Norman, Politico With help from Mary Lee August 22, 2016 […] Quick Hits Whistleblower lawsuit — Medical device giant Medtronic is facing allegations that it promoted a device for uses not approved by FDA, leading to patient injuries and false claims submitted to government payers, STAT reports. The whistleblower suit alleges the… Continue reading Part D pricing trends
Letter to FDA Commissioner re lack of public health and consumer perspectives at drug user fee meeting
August 18, 2016 Robert M. Califf, M.D., Commissioner Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Dear Commissioner Califf: We are writing to express our deep concern regarding the lack of public health and consumer perspectives at the August 15, 2016 Public Meeting on Prescription Drug User Fee Act… Continue reading Letter to FDA Commissioner re lack of public health and consumer perspectives at drug user fee meeting
Center Disappointed in latest FDA-Drug Industry User Fee Agreement: It focuses too much on speed of drug approvals and not enough on safety
Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments of the National Center for Health Research on PDUFA VI Commitment Letter [Docket No. FDA-2016-N-1895] The National Center for Health Research respects the Food and Drug Administration (FDA) and we’re committed to ensuring that… Continue reading Center Disappointed in latest FDA-Drug Industry User Fee Agreement: It focuses too much on speed of drug approvals and not enough on safety
Ask the expert: Is it okay to let my toddler use my iPad for nursery rhymes?
David Coleman, Irish Independent August 17, 2016 Parenting expert and clinical psychologist David Coleman on why a toddler should not use a tablet […]. Even if you limit your daughter’s tablet use to watching and listening to nursery rhymes, it is still bad for her. You need to get rid of the tablet and any other… Continue reading Ask the expert: Is it okay to let my toddler use my iPad for nursery rhymes?
Whistleblower case contends surgical device maker misled FDA — and patients paid the price
Jerome Lew is a Hollywood screenwriter, and what happened to him could have come straight out of a horror film.
In 2009, Lew went to UCLA Medical Center for surgery to relieve numbness and pain in his hands. The operation appeared to be a success. But he later began having trouble speaking. His left eye drooped. He developed severe nerve pain and weakness in his neck, arms, and hands.
PCBs are still causing harm decades after ban
Stephanie Fox-Rawlings, PhD, National Center for Health Research Polychlorinated bisphenyls (PCBs) were banned in the US in the late-1970s, but they still pose a danger to our health. They were widely used in electrical equipment (such as fluorescent light fixtures) and building materials (such as caulk and paint). Today they are found everywhere on Earth… Continue reading PCBs are still causing harm decades after ban
21st Century Cures Act: Yes or No? No: Act’s promise of quick cures is a brew of ultra-hype mixed with snake oil
Imagine that you or someone you love has a fatal disease with no proven treatment. Would you rather be given an unproven experimental treatment for free or would you want to pay more than $100,000 for the drug and hope it works
Would you rather be given that treatment for free by a top physician who carefully monitors your treatment as part of a clinical trial to study whether it works, or, would you rather pay more than $100,000 a year for the same experimental drug and hope your doctor gives you the right dose?
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