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USFDA's ISTAND Pilot Program: Accepts First Submission of AI …

WEBThe acceptance of the first AI-based and digital health technology for neuroscience under the ISTAND Pilot Program marks a significant milestone in the convergence of …

Actived: 8 days ago

URL: https://www.regulatoryaffairsnews.com/post/usfda-s-istand-pilot-program-accepts-first-submission-of-ai-based-digital-tech-for-neuroscience

Health Canada: Guidance on Validation rules for Regulatory …

WEBRegulatory transactions are validated by Health Canada before they are released to sponsors, and if the validation fails due to one or more errors detected, a …

Category: Health Go Health

Health Canada: Guidance Document Management of Drug …

WEBHealth Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA).This guidance …

Category: Health Go Health

Health Canada: Guidance on Master Files Procedures

WEBHealth Canada recently (26 June, 2023) published an updated guidance on "Guidance on Procedures and Administrative Requirements for Master Files".A key …

Category: Health Go Health

Guidance on Developing Drug Shortage Management Plans

WEBThe French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage management plans for …

Category: Medicine Go Health

USFDA Guidance: Conduct of Clinical Trials of Medical Products …

WEBToday (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and the Oncology Center of …

Category: Health Go Health

Colombia INVIMA: Guidelines on the Application related to …

WEBThe National Institute for Food and Drug Surveillance - Invima, informs manufacturers and importers of controlled technology medical devices and biomedical …

Category: Food, Medical Go Health

Health Canada Recommendations: ICH Q3D(R2) Guideline for …

WEBYesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized Guideline for Elemental …

Category: Health Go Health

Health Canada Guidance: Preparation of Regulatory Activities in …

WEBHealth Canada recently (09 June, 2023) published an updated guidance on "Preparation of Regulatory Activities in Non-eCTD Format" that describes the filing …

Category: Health Go Health

UK MHRA Guidance: Medicines: How to Reclassify your Product

WEBToday (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance: Medicines: reclassify your product.” Legal classification determines the level of control over a medicine's supply and is based on how much professional input is needed to diagnose and treat the conditions it may be used …

Category: Medicine Go Health

Singapore's HSA: Consultation on eCTD Implementation & Risk

WEBOn 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions for therapeutic products held from 2 …

Category: Health Go Health

Irelands HPRA's: Medical Device Guide to Clinical Investigations

WEBOn 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations Carried Out in Ireland".CLINICAL INVESTIGATION (CI) is a systematic study involving one or more human subjects that assesses the safety or performance of a medical device.As part of this guide, the Health …

Category: Medical Go Health

Guide to Reporting and Initial Investigation of Quality Defects …

WEBOn 27th August 2021, Irelands Health Products Regulatory Authority (HPRA) released a new "Guide to Reporting and Initial Investigation of Quality Defects in Medicinal …

Category: Health Go Health

South Africa: Information Guideline and Quality and …

WEBRecently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information Guideline" and "Quality and Bioequivalence …

Category: Health Go Health

Philippines FDA: Guidelines on the Application for License to …

WEBYesterday (6 June 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines on the Application for License to Operate of Health …

Category: Food Go Health

Philippines FDA: Guidelines on the Licensing of Retailers of …

WEBOn 8 May 2020, the Philippines Department of Health (DOH) entitled “Revised Guidelines on the Unified Licensing Requirements and Procedures” was …

Category: Health Go Health

Canada Guidance: Regulatory Enrolment Process (REP)

WEBYesterday (29-September 2022) Health Canada updated their guidance on Regulatory Enrolment Process (REP).Health Canada's Regulatory Enrolment Process (REP) …

Category: Health Go Health

GCC Guidance on Labeling Information, SPC and PIL

WEBThe Gulf Health Council released a new updated version of the guidance on 12th August 2021 on “Guidance for Presenting the Labeling Information, SPC and …

Category: Health Go Health