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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
41 views
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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Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...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
137 views
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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Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...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
104 views
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SFDA MD Guidance: Requirements for Clinical Trials of Medical Device
Yesterday (26-December-2022) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Requirements for...
Sharan Murugan
Dec 27, 20222 min read
134 views
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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
48 views
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USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program
Recently on 12-December-2022 USFDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health released...
Sharan Murugan
Dec 14, 20221 min read
22 views
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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
89 views
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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
31 views
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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
8 views
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UK MHRA: MD Guidance - Register Medical Devices to Place on the Market
Earlier today UK Medicines and Healthcare products Regulatory Agency released an updated guidance on "Register medical devices to place...
Sharan Murugan
Dec 6, 20221 min read
17 views
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USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...
Sharan Murugan
Dec 2, 20221 min read
27 views
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USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug
Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...
Sharan Murugan
Dec 2, 20221 min read
125 views
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