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Australia TGA: eCTD AU Module 1 and Regional Information v3.2
The Therapeutic Goods Administration (TGA) of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...
Sharan Murugan
Oct 2, 20242 min read
USFDA Medical Device: Guidance on Dental Products (Dental Impression Materials, Dental Ceramics, Dental Cements and Air Powered Dental Handpieces and Air Motors)
USFDA's Center for Devices and Radiological Health has released four final guidances about dental products, such as Dental Impression...
Sharan Murugan
Sep 28, 20242 min read
India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...
Sharan Murugan
Sep 25, 20242 min read
USFDA Med Dev Guidance: Biocompatibility Testing and Accreditation Scheme for Conformity Assessment (ASCA) Program
USFDAs Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple draft guidance...
Sharan Murugan
Sep 22, 20242 min read
USFDA Guidance: Appeal Options for Mammography Facilities
The USFDA (U.S. Food and Drug Administration) Center for Devices and Radiological Health provides detailed final guidance " Appeal...
Sharan Murugan
Sep 15, 20242 min read
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
The advancement of Artificial Intelligence (AI) is transforming many industries, and the pharmaceutical and regulatory sectors are no...
Sharan Murugan
Sep 15, 20242 min read
USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
USFDA's Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) released a draft...
Sharan Murugan
Sep 6, 20242 min read
USFDA Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and Center for Devices and Radiological Health ...
Sharan Murugan
Aug 31, 20242 min read
India's: Newly Launched Indian Pharmacopoeia (IP) Online Portal and Adverse Drug Monitoring System (ADRMS) Online Portal
India has recently made significant advancements in its healthcare regulatory landscape by launching two new online portals " Adverse...
Sharan Murugan
Aug 27, 20242 min read
UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their comprehensive guidance " Clinical Trials for Medicines –...
Sharan Murugan
Aug 27, 20242 min read
USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information
Yesterday the U.S. Food and Drug Administration (FDA) has released critical guidance documents to streamline the regulatory pathways for...
Sharan Murugan
Aug 24, 20242 min read
USFDA Guidance: Predetermined Change Control Plans for Medical Devices
The U.S. Food and Drug Administration (FDA) has released a guidance document titled " Predetermined Change Control Plans for Medical...
Sharan Murugan
Aug 24, 20242 min read
UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support
The Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance on " Medicines Pipeline Data " on 13 August, 2024 to...
Sharan Murugan
Aug 15, 20242 min read
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...
Sharan Murugan
Jul 31, 20243 min read
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the...
Sharan Murugan
Jul 29, 20242 min read
USFDA Guidance: Application User Fees for Combination Products
The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16...
Sharan Murugan
Jul 16, 20242 min read
New EU Regulations on AI in Medical Devices: Key Insights and Implications
The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...
Sharan Murugan
Jul 15, 20242 min read
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software
Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth...
Sharan Murugan
Jul 13, 20242 min read
USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD
The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental...
Sharan Murugan
Jul 13, 20242 min read
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...
Sharan Murugan
Jul 10, 20242 min read