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Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff Document issued on May 10, 2024. The draft of this document was issued on June 24, 2021 #fda #medicaldevice #medtech #medicaldevcies #wyrobymedyczne

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. #regulatory #update #fda

📋 The U.S. Food and Drug Administration (FDA) plays a vital role in the drug approval process. Learn why this is and what is expected from applicants during this process. - #FDA #Regulatory #DrugApprovalProcess #IND #NDA

Today we remember the creation of the Food and Drug Administration (FDA), the main health surveillance agency in the USA and a guiding light for the global regulatory ecosystem. The institution initially emerged under the Pure Food and Drug Act. It gained relevance and responsibilities in the following decades, especially after the enactment of the Food, Drug, and Cosmetic Act of 1938. As a central drug control initiative in the US, the FDA directly influences debates on regulatory frameworks around the world, which makes it crucial for setting safety, efficacy and quality standards for drugs and medical devices. As an ethical and health benchmark for the top global destination for clinical trials, the FDA plays a central role in promoting good clinical practices and creating efficient and responsible processes for conducting studies. #regulatory #pharma #fda

FDA published new draft guidelines This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations #regulatoryaffairs #regulatory #regulatorysubmission #cmc #dossier #usfda .

During the COVID-19 pandemic, differences between regulatory systems in the Americas impacted health self-sufficiency. In response to this challenge, the Pan American Network for Drug Regulatory Harmonization #PANDRH was created. PANDRH focuses on: 🟢Strengthening regulatory systems through cooperation and exchange. 🟢Develop and implement common proposals aimed at regulatory convergence. 🟢Promote good practices and regulatory science in member states. To meet these objectives, the #NRAs Regulatory Authorities of the region will be members of the XI Conference of the Pan American Network for Drug Regulatory Harmonization #CPANDRH, an initiative to achieve health self-sufficiency and the well-being of the population.

How the FDA Communicates with Stakeholders The U.S. Food and Drug Administration (FDA) recently released two reports outlining its strategies for improving communication with stakeholders and developing guidance documents. The report on communications lists seven ways the FDA communicates with stakeholders, while the report on guidance documents describes the process to create new or update guidance documents, standardized format, and review and release processes.  Read More: https://lnkd.in/g-FE-cAp Author: Dr. Mukesh Kumar, PhD, RAC, | CEO, FDAMAP #fda #stakeholders #fdaregulations #fdacompliance

Day 2 of World Drug Safety Congress Americas in Boston, US continues to be enriched with insights from different regulatory agencies including Health Canada, FDA and EU regulators. The final key note- One world, one standard: The future of pharmacovigilance is being discussed live by this panel. The availabilty of patient safety data from payor databases to regulators has major implications for PV professionals. #healthcanada #drugsafety #patientsafety

#MedSafetyWeek 💊 💉 💊 💉 All medicines can cause #SideEffects 🤢. You can help prevent them by taking your medicines as instructed, in the right dose, at the right time, and in the right way. Also, if #Roche #Ireland #Dublin 🇮🇪 Regulatory Affairs could refrain from perpetrating "ERRORS" (sic) ❗ 😅 with #PatientSafety and #pharmacovigilance rules... (see attached article). #PatientsDeserveBetter 🇮🇪 dear Roche 🇨🇭 Genentech 🇺🇸 , Health Products Regulatory Authority (HPRA), FDA, Simon Harris & Stephen Donnelly To know more and to report side effects (aka Adverse Drug Reactions) to Health Authorities, please check out European Medicines Agency's 🇪🇺 Eudravigilance ➡️ https://lnkd.in/eZttdFhk

Dear Jennifer Foster, many thanks for your comment that says : "the cost of losing one's life for a period of time is much greater." Roche #pharmaceuticals 🇨🇭 has endangered #PatientSafety in #Ireland 🇮🇪 , in infringement with #pharmacovigilance regulations, by providing Irish healthcare professionals and patients with non-compliant marketing materials that failed to provide full comprehensive accurate updated safety information on its marketed medicines, thus misrepresenting the benefits / risks balance of its medicines, out of commercial purposes.   There is absolutely no space for compromising patient safety allowed in the law.   My primary concern as a healthcare professional has always been to genuinely protect patients. But, instead of meeting a company ready to do the right thing, once I performed protected disclosures of their wrongdoing putting patient safety at risk, Roche tried to protect themselves before patients. Roche did not like that I disrupted the status quo, that did not take proper care of patient safety.   I was penalized by Roche for speaking up and making allegations of wrongdoings, for being a #whistleblower, i.e. the #snitch that exposed them. I was heavily victimized in retaliation. I was the snitch to be managed out.   It was totally violent. Roche was incredibly and unbearably violent with me.   Roche put me in an impossible situation in the first place. But, I had absolutely no choice. All I’ve done at Roche was being true to my unwavering commitment to protecting patient safety.   Ultimately, that has left me destroyed and still unable to bounce back. Roche has destroyed my life.   #MedSafetyWeek 💊 💉 #PatientsDeserveBetter #Roche Health Products Regulatory Authority (HPRA) 🇮🇪 Simon Harris 🇮🇪 Stephen Donnelly 🇪🇺 European Medicines Agency 🇪🇺 European Commission