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USFDA Guidance: Post-Warning Letter Meetings Under GDUFA III: A Regulatory Pathway Toward Compliance
In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency  are more crucial than ever. The FDA’s...
Sharan Murugan
2 days ago2 min read
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SFDA Guidance: Requirements for Formal Meetings Between the Drug Sector and Applicants
Th e Saudi Food and Drug Authority (SFDA)Â has issued an updated version (3.1, dated 7 April 2025) of its guideline: " Requirements for...
Sharan Murugan
Apr 232 min read
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Swissmedic’s Guidance: Packaging, Prior Notification Procedures, Fast-Track Authorisation, Regulatory Meetings & Temporary Authorisations
Swissmedic, the Swiss Agency for Therapeutic Products, has released multiple updated guidance documents in April 2025 that impact...
Sharan Murugan
Apr 62 min read
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USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...
Sharan Murugan
Aug 19, 20242 min read
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Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...
Sharan Murugan
Jun 9, 20242 min read
26 views
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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
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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
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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
42 views
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USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...
Sharan Murugan
Feb 19, 20232 min read
38 views
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Pre-Authorisation Procedural Advice for Users of the Centralised Procedure - EMA
This guidance document addresses a number of questions that users of the centralised procedure may have. It provides an overview of the...
Sharan Murugan
Jul 29, 20211 min read
58 views
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