Regulatory Focus

Industry stakeholders have asked the US Food and Drug Administration (FDA) to provide more clarity in a recent draft guidance aimed at helping sponsors determine dose selections using a quantitative systems pharmacology (QSP) approach for first-in-human (FIH) dose in phase 1 trials.  Additionally, they want FDA to provide more regulatory flexibility in changing dose selection, especially during early phases, and harmonize with international standards.

The World Health Organization (WHO) has published its first interim list of 12 global medical device regulators eligible for transitional listed status. Following evaluations, these authorities may transition to formal WHO-listed authorities (WLAs).

The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The documents address three areas: a patient’s performance status, laboratory values, and washout periods.

The European Medicines Agency (EMA) has issued notices stating how it will comply with certain stakeholder information protection under the Data Protection Regulation for EU institutions, bodies, offices, and agencies (EUDPR). Under the regulation that went into effect in 2018, also known as EU 2018/1725, the agency said it is responsible for managing and protecting information received from stakeholders through registration forms and online surveys.

Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council for Harmonisation (ICH), and the US Food and Drug Administration (FDA).

By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked to review to the list of bulk drug substances that can be used in pharmacy compounding.