Observation #1: While NASEM confirmed Haystack’s long-held belief of “outsized impact” to rare disease patients from the?inextricable link between FDA processes, pricing and payer decisions,?nothing in the statute directed NASEM to conflate access, pricing, and payer decisions in the study Congress required of them. We oppose efforts to begin cost containment needed across the US health care system with children dying of rare diseases. https://lnkd.in/ekCjpdpm
Haystack Project的动态
最相关的动态
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Skilled Pediatrician,Engaging Speaker & Advocate.Clinical Expert in Community Autism & ADHD Care Fiercely Compassionate Physician & Public Health Leader Communicating Medical Evidence to Build Shared Decision-Making.
"Federal health agencies were instructed this week not to engage in non-urgent communications until Feb. 1." First question: At what point should an outbreak of an infectious disease be considered urgent? Will we know since MMWR is shuttered? Second question: If you close off almost all the health functions of the federal government as well as much of our foreign relations through the State Department through executive order or other directives, will anybody even blink when you furlough the entire staff of the federal government? Is that part of the plan? What other questions do you have? Maybe we should all call our members of Congress to hold them accountable for the changes in our services. Remember, it's our government, not his.
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Without diverse representation in #clinicaltrials, it is impossible to know if therapies are effective across populations—or to uncover potential adverse reactions. Our diverse patient database supports sponsors in meeting FDA standards for including underrepresented populations in studies. Learn more: https://lnkd.in/ghzHNtbc #DiversityinHealthcare #DiversePatientPopulations #ClinicalTrialDiversity?
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Fauci pushes back on pandemic criticisms before divided House panel >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #productmarketing #pharmaceutical #biotech
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Thoughts on this? >> Fauci pushes back on pandemic criticisms before divided House panel >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #healthcare #pharma #biotech #pharmaceutical
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[WATCH] Healthcare Professionals: You will have patients that may show side effects from a medicine they’ve taken or a recent immunisation – what you can do is report this side effect on behalf of the patient. For a step-by-step guide, watch this useful video on How to report Adverse Drug Reactions (ADRs) & Adverse Event Following Immunisation (AEFIs)? #SAHPRA #medsafetyapp
How to report ADRs and AEFIs As an HCP
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European Regulatory Affairs Editor, @Medtech_Insight @Citeline, formerly @Pharma_Intelligence
What is considered an interruption or discontinuation under the #EUMDR and #EUIVDR that may result in serious harm, or a risk of serious harm, to patients? This critical question is addressed in a recent European Commission Q&A document. Read about what else the document covers on our new-look website! https://bit.ly/3NN17RX
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NAFDAC Zonal Centre at University of Benin Teaching Hospital(UBTH)
#Medsafetyweek#Day 5 ??Studies show that about half of side effects are preventable. By taking your medicines as instructed and reporting suspected side effects to your national medicines authority, you can help us make medicines safer for all. Learn more ?? https://lnkd.in/dwfF2h5P #SouthSouthZonalPharmacovigilanceCenter #WHOUMC #MedSafetyWeek
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In this issue of Dechert Re:Torts, we cover an Alaskan state court dismissal of public nuisance claims against pharmacies selling opioids, new federal rules to promote the "just and efficient conduct” of MDL proceedings, landmark regulations for PFAS finalized by the EPA and more. Learn about each of these topics below.
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Recently, the FDA issued this final guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. This guidance supersedes the previous “510(k) Third Party Review Program” guidance, clarifying how the FDA will use third party review organizations to review 510(k) submissions and may use them to review EUA requests during a future public health emergency.
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?? Early diagnosis and treatment can prevent complications and enable people to live as normal a life as possible. ?? Early diagnosis contributes greatly to improved quality of life and care for people with PI ?? Patient access to care and appropriate treatment can help prevent serious and life-threatening illnesses in people with PI With this in mind, the video campaign “AFFIANCO” ("walk together”) narrated the extraordinary and touching experiences of five patients and their referring doctors, who, from a certain moment of their existence, began to "walk together" in the difficult battle against Primary Immunodeficiencies (PID), rare diseases of the immune system. The initiative was conceived and developed by the Associazione Nazionale Immunodeficienze Primitive - AIP O.d.V. (Italian Association of Primary Immunodeficiencies - AIP O.d.V.) and supported by Kedrion with an unconditional grant. ?? Watch the stories: https://lnkd.in/dPyhpUYE [TIP: Click on the automatic subtitles on youtube for more languages] #WorldPIWeek #WorldPIWeek2024 #PIDs #PrimaryImmunodeficiency #RaiseAwareness
