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USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
In July 2025, the U.S. Food and Drug Administration (FDA) published its updated guidance for industry titled “ Formal Meetings Between...
Sharan Murugan
Jul 19, 20253 min read
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
Jun 18, 20252 min read
SFDA Guidance: Requirements for Formal Meetings Between the Drug Sector and Applicants
Th e Saudi Food and Drug Authority (SFDA) has issued an updated version (3.1, dated 7 April 2025) of its guideline: " Requirements for...
Sharan Murugan
Apr 23, 20252 min read
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 6, 20252 min read
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
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
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
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
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Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...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
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
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