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Aug 192 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...

Jun 92 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...

Sep 21, 20232 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...

Sep 10, 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...

Aug 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Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...

Feb 19, 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The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...

Jul 29, 20211 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...