OpenClinica’s Post

Clinical trials are critical to drug and medical device development, ensuring that new treatments are both safe and effective. But they’re also often an uphill fight for developers, stymied by high costs and patient recruitment challenges. With the right strategies, you can overcome these challenges and achieve FDA approval faster. Our blog covers three proven ways to do just that. Read the blog here: https://lnkd.in/ef9Drg7s

Learn about the drug and medical device approval process. This process follows well-established paths to make sure that medical products are safe and effective when they reach the public. https://lnkd.in/gnZYbT8j Clinical Trials: What Patients Need to Know https://lnkd.in/g7TiNh8f New Drug Development and Review Process https://lnkd.in/gyjYcemu

#MHRA Launches Consultation for Common Specification Requirements for IVDs as of 21st May 2024 MHRA is inviting members of the public, including patients, medical device researchers, developers, manufacturers and suppliers and other industry professionals to provide their views on the introduction of common specification requirements to the regulatory framework before #IVD devices can be placed on the GB market A key area they are looking for views and feedback on is the #CTDA process for #covid19 tests The consultation deadline is June 14th at 11.59pm - you can respond online with the link below and following the instructions #regulatoryaffairs #IVDR #diagnostics #invitrodiagnostics https://lnkd.in/e_Ks4Xax

Clinical trials are critical to drug and medical device development, ensuring that new treatments are both safe and effective. But they’re also often an uphill fight for developers, stymied by high costs and patient recruitment challenges.  With the right strategies, you can overcome these challenges and achieve FDA approval faster. Our blog covers three proven ways to do just that. Read it here: https://bit.ly/3vBlZ9v #MedicalInnovations #ImprovedLives #TreatmentSuccess #DHLifeSciences

You're invited to take part in the Consultation Specifications Requirements for IVD's to have your say regarding the #CTDA (coronavirus test device approvals) moving forward in line with the regulatory framework of getting IVD's on the GB market and whether the CTDA application be removed Currently all manufacturers or distributors supplying COVID-19 tests must apply to the MHRA. Their product must meet the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 Deadline is 14th June 11.59pm Any queries you can always speak to us at IVDeology on info@ivdeology.co.uk or drop a comment below #IVDR #IVD #covid19 #invitrodiagnostics #regulatoryaffairs

'“The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased need for pre-market clinical investigations for certain higher risk devices to verify their safety and clinical performance,” said MDCG. “These increased clinical evidence requirements present a challenge for devices specifically intended for use in rare diseases/conditions, or in specific indications for rare cohorts of patients with an otherwise non-rare disease/condition.”   “The increased, and at times unpredictable, financial costs associated with compliance with MDR requirements, including MDR certification, can make it prohibitive for manufacturers to place orphan devices on the EU market, as the low volumes of sales may not offset the financial costs,” the group added.' When they say that medical devices are going down the drug development route they really mean it. Because of these same reasons we don't have drugs for many rare diseases - the cost of developing the product is too high and there are very few patients who can be treated. Everyone is so keen in involving patient groups in research but I would like to see the regulators sitting down around the table with patients with rare diseases before they develop their regulations. #MDR #medicaldevices #orphandevices #EU

Struggling to find the right formula for your early-phase clinical trials? This webinar explores strategies to optimize your program and avoid costly mistakes. #drugdevelopment #formulations https://ow.ly/u74Y50QOH3R

In-vitro diagnostic medical devices (IVDs) play a key role in the UK's healthcare system. As the IVD industry continues to advance rapidly, so does the future regulatory framework for medical devices. Currently, the MHRA is focused on delivering the future regulatory framework for medical devices. Some key achievements by the MHRA include: ➡️ Publication of the government response to the public consultation on the future regulation of medical devices in the United Kingdom. ➡️ The establishment of an Innovative Devices Access Pathway pilot. ➡️ Guidance on Software as a medical device ➡️ The laying of regulations for IVD devices in Northern Ireland to lay down proportionate penalties. Learn more: https://heyor.ca/1RDFOp #IVD #MedicalDevices #InVitroDiagnosticMedicalDevices

Drug-coated balloons (DCBs) have emerged as a potentially useful tool for preventing restenosis following hemodialysis access angioplasty. While evidence in favor of DCBs, continues to mount, results with conventional DCB's have been less consistent vs PTA. Concept Medical is excited to receive it's 5th US FDA investigational Device Exemption ( IDE) approval for its Worlds 1st CE commercialized Sirolimus DCB with US FDA breakthrough designation for Magic Touch AVF , indicated for treatment of dysfunctional Arteriovenous Fistula . The approval paves the way to complete pivotal safety and efficacy study for extending the benefits of this novel technologies available in over 80 countries worldwide , to patients with End State Renal Disease in the United States. # Gamechanger Technologies # Largest and Longest Studied Clinical Trial Program # 5th US FDA IDE approval

MDCG guidance tries to reduce burden of bringing orphan devices to EU market Regulatory News - 25 June 2024 - Ferdous Al-Faruque Manufacturers developing orphan medical devices in the EU should be given extra leeway to bring their products to market, especially considering the higher evidence threshold set by the Medical Device Regulations (MDR), according to a new guidance from the Medical Device Coordination Group (MDCG). The group also emphasized that manufacturers may need to rely more on postmarket studies and non-clinical data to support such products.   On 25 July, MDCG published guidance for manufacturers and notified bodies detailing considerations for defining an orphan device and the potentially limited evidence needed to determine whether it has proven to be safe and effective.