EMA Confirms Suicidal Thoughts with Finasteride — Detailed summary, implications, and a practical pharmacovigilance / manufacturer action plan
Source documents: EMA PRAC communications and referral page (May–June 2025). European Medicines Agency (EMA)+1 Executive summary — the one-minute version What PRAC found (evidence & conclusions) Key regulatory changes and public health measures Clinical and public-health implications (who should worry and what to do) Impact on manufacturers — regulatory & operational checklist Manufacturers (brand and […]
EMA’s Update on Azithromycin Use — May 23, 2025
Key Regulatory Shift The European Medicines Agency’s (EMA) CHMP recommended updating the approved uses of azithromycin (oral and IV) to combat rising antimicrobial resistance (AMR)—particularly given its designation in WHO’s Watch category, which flags antibiotics at higher risk of driving resistance. (turn0search0) What’s Changed? Refined and Harmonized Indications Approvals have been narrowed and standardized, covering […]
Deep brief — Formal Meetings Between FDA and Sponsors/Applicants of BsUFA Products
Guidance for Industry (CDER & CBER, July 2025) — what it says, why it matters, and exactly what regulatory, pharmacovigilance (PV), quality, clinical and commercial teams must do day-to-day. U.S. Food and Drug Administration Quick summary (the headline) This FDA guidance codifies how sponsors of biosimilar or interchangeable biologic products should request, prepare for, run, […]
Deep Brief — Medical Device User Fee Small Business Qualification & Determination (FDA guidance, July 31, 2025)
What it is, why it matters, and exactly what manufacturers — including regulatory, PV/PS (pharmacovigilance / product safety), quality and finance teams — must do Short version: This FDA guidance explains how device and biologics firms can qualify as a “small business” for reduced MDUFA user fees (and for a one-time waiver of a first […]
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
In March 2022, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” This document provides detailed recommendations for industry and academic sponsors involved in the development of CAR T cell therapies, aiming to streamline the development process and ensure the […]
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of pharmaceutical products. One of its key responsibilities is monitoring post-market safety through pharmacoepidemiologic studies. The FDA’s guidance document, “Conducting and Reporting Pharmacoepidemiologic Safety Studies,” provides detailed recommendations on the design, conduct, and reporting of such studies. Overview […]
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. One of its key regulatory requirements is the Medical Device Reporting (MDR) system, which mandates manufacturers to report adverse events and device malfunctions. The FDA’s guidance document, “Medical Device Reporting for Manufacturers,” provides clarity on […]
Electronic Submission Template for Medical Device De Novo Requests
The U.S. Food and Drug Administration (FDA) has released guidance on the importance of diversity in clinical trials to ensure that study populations reflect the demographics of the intended treatment population. The document, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” provides recommendations for sponsors to develop […]
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
The U.S. Food and Drug Administration (FDA) has issued guidance to enhance the transparency and consistency of benefit-risk assessments in the regulatory review process for new drug applications (NDAs) and biologics license applications (BLAs). The document, “Benefit-Risk Assessment for New Drug and Biologic Applications,” outlines how the FDA evaluates the therapeutic benefits and associated risks […]