Regulatory Rapporteur July/August 2026 – Contents
Therapeutics: Navigating diverse regulatory pathways
Drug development and regulatory pathways across therapeutic areas
The development of novel influenza drugs: Current regulatory challenges
Advancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction
Navigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives
Environmental risk assessment of human medicinal products in the EU: Legacy APIs, data reuse, and the governance bottleneck after the 2024 guideline revision
Medical device standards update: July 2026
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FDA consults on the regulation of GenAI-enabled medical devices
The US Food and Drug Administration (FDA) has released a discussion paper to gather feedback on topics relevant to the regulation of generative artificial intelligence (GenAI)-enabled medical devices.
FDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
New diabetes treatment and a Vetmedin referral: Inside the CVMP July 2026 meeting
The July meeting of the Committee for Veterinary Medicinal Products (CVMP) covered product opinions, a Union referral, scientific advice outcomes, and several guideline updates spanning fixed combinations, novel RNA-based therapies and pharmacovigilance.
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CHMP July meeting brings first-of-its-kind eye implant and oral psoriasis breakthrough
At its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for marketing authorisation (three generics, one biosimilar, and eight extensions of indication), while issuing negative opinions on three applications.
CVMP June 2026 meeting update: Vaccines, guideline reviews and an AMR strategy refresh
The Committee for Veterinary Medicinal Products (CVMP) met on 16-18 June 2026. Alongside its usual product decisions, the Committee advanced two guideline reviews for sponsors working on vaccines and other immunological products.
FDA launches new guidance on development of psychedelic drugs to treat medical conditions
The US Food and Drug Administration (FDA) has issued its final guidance for drug development programmes evaluating the therapeutic potential of psychedelic drugs.
USP 2025 Annual Drug Shortages Report: Shortages decline but duration increases
In June 2026, the United States Pharmacopeia (USP) released their 2025 Annual Drug Shortages Report, reviewing trends in drug shortages affecting the United States.
RegRapPod − InConversation with Aman Khera
InConversation talks about opportunities and disruptors within the regulatory affairs industry with Aman Khera
RegRapPod − InConversation with Magda Papadaki
InConversation talks portfolio careers with Magda Papadaki and Ming Ewe
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