Updated EU M1 eCTD Specification The EU eCTD Module 1 Specification has been updated to v3.1. EU M1 eCTD Specification v3.1 – Updated Guidelines: Release notes with practical information on changes are provided below. There are also changes to the DTD in this version (version 3.1), and the validation criteria was updated to v8.0… Continue reading Regulatory update EU eCTD Validation Criteria
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FDA FAERS Electronic Submissions for Postmarketing & Premarketing ICSRs
FDA Adverse Event Reporting System (FAERS) Electronic Submissions: To assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
International Recognition of Medical Devices | MHRA
Statement of Policy Intent: International Recognition of Medical Devices The UK Medicines and Healthcare products Regulatory Agency (MHRA) aims to facilitate quicker and more efficient access to medical devices by leveraging the expertise and decision-making processes of international regulatory partners. This initiative will benefit patients by allowing the MHRA to recognize approvals from other regulatory… Continue reading International Recognition of Medical Devices | MHRA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA: The purpose of this guidance is to provide recommendations for abbreviated new drug applications (ANDAs) or Prior Approval Supplements (PAS) to holders of Type II active pharmaceutical ingredient (API)… Continue reading Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry
Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry Appropriate Matter for a Request for Reconsideration? Refuse-to-receive decision Tentative approval letter
US FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry
US FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry: As of October 10, 2024, under section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)), HHS Secretary Becerra has declared public health emergencies (PHEs) in North Carolina, Florida, Georgia, Tennessee, and South Carolina due to the impacts of Hurricane Helene,… Continue reading US FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry
FDA Regulation of Dietary Supplements Under DSHEA
The regulation of dietary supplements by the FDA under the Dietary Supplement Health and Education Act of 1994 (DSHEA) emphasizes the responsibility of manufacturers and distributors to ensure their products are safe and accurately labelled. Here are some key points regarding recent updates and resources related to dietary supplements:
CDSCO Revised Pharmacovigilance Guidance on Extending Event Reporting Deadline
Central drug standard control organizations has released version 2.0 pharmacovigilance guidance, enacting changes such as extending the deadline for reporting non-serious adverse events and revising record-keeping requirements.
Dietary Supplements
The FDA oversees both finished dietary supplement products and dietary components. The FDA regulates dietary supplements differently than it does “conventional” foods and drugs. According to the Dietary Supplement Health and Education Act of 1994 (DSHEA):
Control of Nitrosamine Impurities in Human Drugs Guidance for Industry
Nitrosamine impurities guidance updated with more information related to root causes of formation, mitigation and implementation of recommended AI limits and setting of specification for the recommended acceptable intake in drug products. Guidance has updated from February 2021 Revision 1 to September 2024 Revision 2 complete details provided below: