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Author Topic: FDA  (Read 10025 times)

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Offline LinksEtc

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Re: FDA
« Reply #105 on: April 26, 2016, 12:33:33 PM »
"The FDA, for only the second time ever, wants to ban a medical device. Here’s why."
https://www.washingtonpost.com/news/to-your-health/wp/2016/03/21/what-do-powdered-surgical-gloves-and-prosthetic-hair-fibers-have-in-common-the-fda-doesnt-like-them/?postshare=5591458581633246&tid=ss_tw

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The consumer advocacy group Public Citizen, which petitioned the FDA in 1998 to ban powdered surgical latex gloves, on Monday chastised the agency for waiting so long to take such an action.

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"Internists, Specialists Lack Knowledge About FDA Drug Approval Process"
Tara Haelle
April 12, 2016
Medscape

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Most doctors do not fully understand the drug approval process for the US Food and Drug Administration (FDA) or the FDA's "breakthrough" drug classification, according to a survey published April 12 in JAMA.
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"Physicians tended to overestimate the minimum evidence of efficacy required of new drugs," write Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women's Hospital in Boston, Massachusetts, and his colleagues. "Similarly, many misinterpreted the term breakthrough—believing these drugs were supported by stronger evidence than required by the statute."





« Last Edit: April 26, 2016, 06:53:08 PM by LinksEtc »
FARE's Food Allergy & Anaphylaxis Emergency Care Plan
http://www.foodallergy.org/document.doc?id=234

Confusion between anaphylaxis and asthma:
Standard Protocol for "Asthma Action Plans"

Offline LinksEtc

  • Member
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  • Posts: 2,701
Re: FDA
« Reply #106 on: April 26, 2016, 12:40:21 PM »
"Document Claims Drug Makers Deceived a Top Medical Journal"
http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html?_r=1

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They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe.


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"Can Regulators Keep Up with the Supplements Industry?"
http://www.pbs.org/wgbh/frontline/article/can-regulators-keep-up-with-the-supplements-industry/

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In other words, the makers of supplements don’t have to win FDA approval before bringing a product to market, unless it contains a new ingredient that’s never been marketed before. The FDA does oversee labeling, but it usually can’t determine whether a manufacturer is following its guidelines until there’s a problem.

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the agency only inspects a fraction of companies



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Hashtag Prescription
The hidden cost of crowd-sourcing a cure
By Helen Ouyang
http://harpers.org/archive/2016/06/hashtag-prescription/1/

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Because brincidofovir was still undergoing clinical trials — contrary to Aimee’s post, the drug had not yet been proved safe or effective — it could be procured only through a special FDA protocol that allows doctors to prescribe experimental drugs.

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The ethical complexities of compassionate use were perhaps nowhere more evident than in my conversation last July with Richard Plotkin, the activist who had vilified Chimerix and Moch. He told me that he had become much more informed about compassionate use since the #savejosh crusade.

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“When you’re desperately ill, you’re kind of coerced by your disease. The fact that you’re desperate and you’re willing to take anything doesn’t mean the best way we can respond is to honor that request,” he said. “Because we can make you die faster, and we can absolutely make you die sicker.”






« Last Edit: May 15, 2016, 04:16:59 PM by LinksEtc »
FARE's Food Allergy & Anaphylaxis Emergency Care Plan
http://www.foodallergy.org/document.doc?id=234

Confusion between anaphylaxis and asthma:
Standard Protocol for "Asthma Action Plans"

Offline LinksEtc

  • Member
  • ***
  • Posts: 2,701
Re: FDA
« Reply #107 on: April 26, 2016, 02:26:11 PM »
CBS proclaims ‘cancer breakthrough’ – doesn’t explain what FDA means by that term
http://www.healthnewsreview.org/2016/05/cbs-proclaims-cancer-breakthrough-doesnt-explain-what-fda-means-by-that-term/

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“When you hear the word breakthrough, it’s understandable to think that it means something definitively or a game changer,” said study co-author Dr. Steven Woloshin, a professor of medicine at the Dartmouth Institute. “But it gets confusing because the FDA uses it in a very different way.”

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And since it is lay people to whom the CBS News is targeted – by definition, a “broadcast” audience – I think the network should stop and explain what FDA breakthrough status means before putting up a “CANCER BREAKTHROUGH” graphic for about 40 seconds to lead a newscast.


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"What Drug Ads Don’t Say"
http://www.nytimes.com/2016/04/24/opinion/sunday/what-drug-ads-dont-say.html

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the ad omits something that most consumers would like to know: There are many older and cheaper treatments that are just as effective

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Of course, the goal of drug companies is not to educate, but to sell products.

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What I propose is a universal scorecard for all new drugs, to be overseen by the Food and Drug Administration, with information on how their cost and effectiveness measure up against similar medications.


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"FDA sued for hiding too much info about its expert panel members"
https://www.statnews.com/pharmalot/2016/04/28/fda-secrets-redactions-drugs/

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At issue is an agency practice to redact portions of the resumes submitted by the scientific and medical experts who serve on FDA advisory committees, according to a lawsuit filed on Wednesday by Public Citizen in a federal court in Washington. The consumer group charged the redactions are “unlawful.”


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Bias






« Last Edit: May 16, 2016, 07:41:20 AM by LinksEtc »
FARE's Food Allergy & Anaphylaxis Emergency Care Plan
http://www.foodallergy.org/document.doc?id=234

Confusion between anaphylaxis and asthma:
Standard Protocol for "Asthma Action Plans"