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Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing

Many of the bispecific antibodies (BsAbs) approved by global regulators have yet to demonstrate robust clinical benefit beyond surrogate endpoints that led to their initial approval, according to research published in BioDrugs.

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy studies.

Last month, the US Food and Drug Administration (FDA) and the pharmaceutical industry concluded a series of subgroup meetings toward the reauthorizing the Prescription Drug User Fee Program (PDUFA VII).

The European Medicines Agency (EMA) has released a concept paper proposing a future reflection paper on the development of non-clinical proof-of-concept (POC) studies to support novel oncology treatments for the pediatric population.

The pharmaceutical industry has expressed a need for greater clarity regarding the timeline for converting quality information for existing drug and biologics dossiers to the common technical document (CTD) format described in the International Council for Harmonisation's (ICH) M4Q(R2) guideline.

The European Medicines Agency (EMA) has announced that its pilot program for the stepwise pediatric investigation plan (sPIP) has successfully supported timely pediatric development while maintaining scientific rigor. This program will be incorporated into the existing pediatric regulatory landscape.

BETHESDA, MD – Companies should increase their efforts to address issues and test their electronic Common Technical Document (eCTD) Version 4.0 before it becomes mandatory, according to regulators with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The US Food and Drug Administration (FDA) officially launched its PreCheck pilot program on Sunday and is now accepting applications from manufacturers who wish to participate. In announcing the program, the agency rejected the pharmaceutical industry's suggestions to allow existing facilities to participate in the program.

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

US Food and Drug Administration (FDA) Commissioner Marty Makary said he wants to see the same sense of urgency given to Operation Warp Speed applied to the agency's Commissioner's National Priority Voucher (CNPV) program.

Biosimilar industry groups have expressed support for a recent guidance from the US Food and Drug Administration (FDA) that recommends the elimination of comparative efficacy studies (CES) for most biosimilar products and instead would rely on comparative analytical assessments (CAAs) to demonstrate comparability.