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EMA Checklist: Updated Validation checklist for Type II quality variations
Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality...
Sharan Murugan
Feb 14, 20231 min read
Pakistan DRAP Guidance: GMP for Manufacturing Sites of Drugs
Earlier today (09-January-2022), the Drug Regulatory Authority of Pakistan released an updated guidance on "Good Manufacturing Practices...
Sharan Murugan
Feb 9, 20231 min read
South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products
Earlier today (07-February-2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for...
Sharan Murugan
Feb 7, 20231 min read
Ireland's HPRA: Guide to Clinical Trial Applications
Recently in January, the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "HPRA Guide to Clinical Trial...
Sharan Murugan
Feb 2, 20231 min read
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
Recently (30 January 2023) Health Canada updated their guidance document on "Conduct and Analysis of Comparative Bioavailability...
Sharan Murugan
Feb 1, 20231 min read
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...
Sharan Murugan
Feb 1, 20231 min read
USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products
Earlier today, the FDA published a draft guidance for the industry titled, "Considerations for the Design and Conduct of Externally...
Sharan Murugan
Jan 31, 20231 min read
MHRA Guidance: Innovative Licensing and Access Pathway (updation)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance information on the Innovative Licensing and...
Sharan Murugan
Jan 31, 20231 min read
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...
Sharan Murugan
Jan 17, 20231 min read
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form
Yesterday (16-January-2023) European Medicines Agency (EMA) released an udated guideline "Information note on the format and validity...
Sharan Murugan
Jan 16, 20232 min read
Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal
Recently on 4th January, 2023 the Philippines Food and Drug Administration (FDA) released a draft guideline for comments i.e;...
Sharan Murugan
Jan 8, 20231 min read
Irelands HPRA's: Guide to Fees for Human Products
On 3rd January 2023, Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Fees for Human Products"....
Sharan Murugan
Jan 8, 20231 min read
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...
Sharan Murugan
Jan 4, 20231 min read
Swissmedic Guidance: Temporary Authorisation to Use an Unauthorised Medicinal Product
A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a...
Sharan Murugan
Dec 27, 20221 min read
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...
Sharan Murugan
Dec 27, 20221 min read
ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...
Sharan Murugan
Dec 27, 20222 min read
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
Yesterday (14-December-2022), USFDA published the revised final guidance “Failure to Respond to an ANDA Complete Response Letter Within...
Sharan Murugan
Dec 15, 20221 min read
USFDA Proposal: IND Annual Reports for More Comprehensive, Consistent with International Regulations
Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new...
Sharan Murugan
Dec 8, 20221 min read
USFDA Guidance: Homeopathic Drugs Products
Earlier Today (07-December-2022), the U.S. Food and Drug Administration issued a final guidance, "Drug Products Labeled as Homeopathic...
Sharan Murugan
Dec 7, 20221 min read
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...
Sharan Murugan
Dec 6, 20221 min read