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USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance
Earlier this week (26 & 29 February 2024) the the U.S. Food and Drug Administration (FDA) released two guidances "Reporting Amount of...
Sharan Murugan
Mar 2, 20242 min read
TGA MD Guidance: Medical Device Labelling Obligations
On Monday (19 February, 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance on the "Medical Device...
Sharan Murugan
Feb 22, 20241 min read
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
Today (13 February 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, Center for Devices...
Sharan Murugan
Feb 13, 20242 min read
USFDA Guidance: "Understanding FDA's QMSR Final Rule: What You Need to Know for the Transition Period"
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit...
Sharan Murugan
Feb 4, 20242 min read
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...
Sharan Murugan
Jan 31, 20241 min read
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...
Sharan Murugan
Jan 28, 20242 min read
USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience
A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by...
Sharan Murugan
Jan 23, 20242 min read
WHO Guidance: Ethics and Governance of Artificial Intelligence for Health
The World Health Organization (WHO) released new guidelines (18 January 2023) on ethics and governance of large multi-modal models...
Sharan Murugan
Jan 20, 20241 min read
MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device
Earlier today (17 July, 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Notify the...
Sharan Murugan
Jan 16, 20242 min read
South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation
Earlier today (16 January, 2024) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline For...
Sharan Murugan
Jan 16, 20241 min read
USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions
Yesterday (08 January, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...
Sharan Murugan
Jan 9, 20241 min read
India CDSCO: Launching of National Single Window System (NSWS) Portal
To address the challenges in the management of medical devices, India's Central Drugs Standard Control Organization (CDSCO) has...
Sharan Murugan
Jan 2, 20241 min read
Saudi Arabia’s (SFDA): Requirements for Clinical Trials of Medical Devices
The Saudi Food and Drug Authority (SFDA) issued a comprehensive updated guidance titled "Requirements for Clinical Trials of Medical...
Sharan Murugan
Dec 30, 20231 min read
USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices
Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...
Sharan Murugan
Dec 19, 20232 min read
Philippines FDA: Guidance on Use of FDA eServices Portal for the Initial Application of CMDN
On 4 Decemberber 2023, the Philippines FDA released draft guidelines on the "Use of the Food and Drug Administration eServices Portal...
Sharan Murugan
Dec 6, 20232 min read
UK MHRA: Guidance on Register Medical Devices to Place on the Market
Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register...
Sharan Murugan
Dec 3, 20231 min read
Australia TGA: Clinical Evidence Guidelines
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance "Clinical Evidence" on 23 November 2023,...
Sharan Murugan
Nov 26, 20232 min read
Swiss Medic: Biosimilar Authorisation Guidance
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...
Sharan Murugan
Nov 26, 20232 min read
South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments
Last Friday (17 November 2023) the South African Health Products Regulatory Authority (SAPHRA) released updated guidance on "Guideline On...
Sharan Murugan
Nov 19, 20231 min read
USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidances related...
Sharan Murugan
Nov 19, 20232 min read