Regulatoryrapporteur.org

Understanding key components of a clinical evaluation

WEBMED DEV Rev 4 identifies five stages for clinical evaluation – up from four in the previous revision. The first stage is now Stage 0 — scoping the clinical evaluation, while Stage 1 …

Actived: 8 days ago

URL: https://www.regulatoryrapporteur.org/medical-devices/understanding-key-components-of-a-clinical-evaluation/225.article

Utah law to permit non-FDA-approved stem cell therapies

WEBIt determines that Utah healthcare providers: “…may perform a placental stem cell therapy that is not approved by the FDA…” so long as the provider prominently …

Category: Health Go Health

Good safety profile of COVID-19 vaccines declared by ICMRA

WEBA statement that confirms the good safety profile of COVID-19 vaccines has been published by the International Coalition of Medicines Regulatory Authorities …

Category: Medicine Go Health

A review of Project Orbis: An initiative enabling faster patient …

WEBFirst approval via Project Orbis. On 17 Sep 2019, the US FDA announced that accelerated approval was granted to a supplement for Lenvima (lenvatinib) in …

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A regulatory lens on an industry imperative: Diversity in clinical

WEBTable 1: Oncology – guidance to increase inclusion issued by the FDA. Title of guidance Date of issuance Status ; Considerations for the inclusion of adolescent …

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First three countries added to WHO-Listed regulatory agencies

WEBSingapore’s Health Sciences Authority (HSA), South Korea’s Ministry of Food and Drug Safety (MFDS) and the Swiss Agency for Therapeutic Products …

Category: Food Go Health

Equal access to medicines: finding the balance

WEBThis edition of TOPRA’s Regulatory Rapporteur journal explores some of the challenges faced by regulatory professionals around the world; from the African regulatory …

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Jacci Squire Author Regulatory Rapporteur

WEB21/08/22. Data quality is becoming increasingly critical to the success of medicinal product applications and has the potential to increase the speed and efficiency of medicines …

Category: Medicine Go Health

The application of patient preference information Journal

WEBRegulatory authorities are encouraging the submission of patient experience data, including patient preference information (PPI). We provide an overview of PPI and …

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MHRA plans medical device technologies streamlined pathway

WEBA pilot regulatory pathway from the MHRA, which should allow it to better support manufacturers developing novel medical technologies, will launch later this year.

Category: Medical Go Health

EMA/HMA publish workplan for the responsible use of AI

WEBThe EMA and the Heads of Medicines Agencies (HMA) have published a ‘multi-annual AI workplan 2023-2028’ to facilitate the safe and effective use of artificial …

Category: Medicine Go Health

NHS Pharmacy First offers an alternative to GPs in England

WEBThe PFS in England replaces the Community Pharmacist Consultation Service (CPCS) which had allowed pharmacists to supply urgent repeat medication and …

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Patients are at the centre of everything Interview Regulatory

WEBYaneth Giha, Executive President, FIFARMA, finds and implements solutions to enhance patient outcomes. She discusses the Association’s focus and mission, and …

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Overview of medical device regulations in Canada

WEBDespite being a relatively small jurisdiction, Canada’s Medical Device Directorate (MDD) plays a dynamic role in shaping global regulations and taking a leadership role in …

Category: Medical Go Health

Navigating the regulatory terrain down under: trends in Australia …

WEBAustralia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators …

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Advancing global healthcare together Editorial Regulatory …

WEBAn annual fixture since 2004, TOPRA’s Symposium is Europe’s premier conference for regulatory affairs professionals with dedicated programme streams for …

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India backs ambitious expansion in spending to support medical …

WEBIndia’s National Medical Devices Policy 2023 is expected to boost growth of the country’s homegrown medical devices sector and contribute to meeting the …

Category: Medical Go Health

Sink or swim: the changing tides of device regulation

WEBShifting our focus to the EU Medical Device Regulation (MDR) transition, this issue also delves into the impact of the extended transition period and the implications of …

Category: Medical Go Health

Regulatory guidelines for nutraceuticals in India Journal

WEBRegulatory guidelines fornutraceuticals in India. Regulatory guidelines for. nutraceuticals in India. By Nikita Kolekar and Kinjal Bera 18/05/23. The regulatory …

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