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USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products
The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...
Sharan Murugan
Sep 21, 20232 min read
31 views
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USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...
Sharan Murugan
Sep 21, 20231 min read
27 views
0 comments
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
Sharan Murugan
Sep 20, 20232 min read
26 views
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USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products
Earlier this Monday (18 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center...
Sharan Murugan
Sep 20, 20232 min read
19 views
0 comments
TGA Guidance: Submitting data in the eCTD format
Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...
Sharan Murugan
Sep 11, 20231 min read
125 views
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USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
Earlier today (11 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for...
Sharan Murugan
Sep 11, 20232 min read
18 views
0 comments
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for...
Sharan Murugan
Sep 10, 20232 min read
11 views
0 comments
Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines
Yesterday (21-August-2023) Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...
Sharan Murugan
Aug 22, 20232 min read
39 views
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USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
The U.S. Food and Drug Administration (FDA) released its final guidance this Tuesday (15 August 2023), "Informed Consent: Guidelines for...
Sharan Murugan
Aug 17, 20231 min read
39 views
0 comments
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...
Sharan Murugan
Aug 10, 20232 min read
38 views
0 comments
USFDA Guidance: QTc Information in Prescription Drug & Biological Product Labeling
Recently on 08 August 2023, the United States Food & Drug Administration's Oncology Center of Excellence, Center for Drug Evaluation and...
Sharan Murugan
Aug 10, 20232 min read
26 views
0 comments
USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
Sharan Murugan
Aug 4, 20232 min read
124 views
0 comments
USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
Sharan Murugan
Aug 4, 20232 min read
34 views
0 comments
USFDA Guidance: Assessing User Fees -BsUFA III: Biosimilar User Fee Amendments of 2022
Today (31 July 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
Sharan Murugan
Aug 1, 20232 min read
14 views
0 comments
Canada HC Guidance: Nitrosamine Impurities in Medications
Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about...
Sharan Murugan
Jul 30, 20231 min read
28 views
0 comments
UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime
Guidance on Renewing Marketing Authorisations Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency...
Sharan Murugan
Jul 30, 20231 min read
73 views
0 comments
EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation
The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...
Sharan Murugan
Jul 24, 20232 min read
14 views
0 comments
Ireland HPRA: Guidance on Parallel Imports of Human Medicines
Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Parallel Imports of Human Medicines" last week (12...
Sharan Murugan
Jul 15, 20232 min read
32 views
0 comments
USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance
Last Week (13th & 14th July 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
Sharan Murugan
Jul 15, 20232 min read
29 views
0 comments
EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information
Yesterday (14 July 2023) the European Medicines Agency released an updated regulatory and procedural guideline "Compilation of Union...
Sharan Murugan
Jul 15, 20231 min read
350 views
0 comments