Regulatory Focus

Most adult cancer drugs approved by the US Food and Drug Administration (FDA) over the past two decades were regular approvals for expanded indications based on surrogate endpoints, rather than accelerated approvals, according to a study published in JAMA on Thursday.

The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide products. These PSGs focus on peptide drugs used to treat conditions such as obesity, type 2 diabetes, osteoporosis, and macular degeneration.

EFPIA has called for lawmakers to go beyond the reductions in clinical trial approval times proposed in the Biotech Act.

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

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

Industry stakeholders have asked the US Food and Drug Administration (FDA) to provide more clarity in a recent draft guidance aimed at helping sponsors determine dose selections using a quantitative systems pharmacology (QSP) approach for first-in-human (FIH) dose in phase 1 trials.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.