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Australia TGA: eCTD AU Module 1 and Regional Information v3.2
The Therapeutic Goods Administration (TGA)Â of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...
Sharan Murugan
Oct 2, 20242 min read
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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
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UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence
Yesterday (27 September 2024) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on " Applying...
Sharan Murugan
Sep 28, 20242 min read
80 views
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Malaysia’s NPRA: Guidance for Bioequivalence Inspection
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated regulatory guidance on the conduct of bioequivalence...
Sharan Murugan
Sep 25, 20242 min read
34 views
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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
32 views
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USFDA Guidance: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
The USFDA's Center for Biologics Evaluation and Research (CBER) has released the final guidance document , titled “ An Acceptable...
Sharan Murugan
Sep 25, 20242 min read
19 views
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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USFDAs Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple draft guidance...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
31 views
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SFDA Guidance: Conducting Clinical Trials with Decentralized Elements & Integrating Randomized Controlled Trials
Guidance: Conducting Clinical Trials With Decentralized Elements The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation...
Sharan Murugan
Sep 22, 20242 min read
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EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
On 16 September 2024 the European Medicines Agency (EMA) provided a detailed guide " IRIS guide for applicants - How to create and submit...
Sharan Murugan
Sep 21, 20242 min read
48 views
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USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Sep 15, 20242 min read
52 views
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USFDA Guidance: Amendments to Abbreviated New Drug Applications (ANDAs) Under GDUFA
FDA's Center for Drug Evaluation and Research revised the final guidance last week titled " ANDA Submissions | Amendments to Abbreviated...
Sharan Murugan
Sep 15, 20242 min read
63 views
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USFDA Guidance: Appeal Options for Mammography Facilities
The USFDA Â (U.S. Food and Drug Administration) Center for Devices and Radiological Health provides detailed final guidance " Appeal...
Sharan Murugan
Sep 15, 20242 min read
9 views
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EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
The advancement of Artificial Intelligence (AI) Â is transforming many industries, and the pharmaceutical and regulatory sectors are no...
Sharan Murugan
Sep 15, 20242 min read
24 views
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UK MHRA: Windsor Framework: Wholesalers & Manufacturers Guidance & Labelling and Packaging Requirements
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released 2 updated essential guidances " Wholesalers &...
Sharan Murugan
Sep 15, 20242 min read
18 views
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South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...
Sharan Murugan
Sep 9, 20242 min read
60 views
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USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
USFDA's Center for Devices and Radiological Health (CDRH)Â and the Center for Biologics Evaluation and Research (CBER) released a draft...
Sharan Murugan
Sep 6, 20242 min read
38 views
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USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs
Earlier today (04 September, 2024) U.S. Food and Drug Administration's Center for Drug Evaluation and Research released the second...
Sharan Murugan
Sep 4, 20242 min read
87 views
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USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide
The USFDA Center for Drug Evaluation and Research issued the final guidance today (03 September 2024) " Bioresearch Monitoring...
Sharan Murugan
Sep 3, 20242 min read
41 views
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