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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.

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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.

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

The US Food and Drug Administration (FDA) has finalized guidance on promotional labeling and advertising for prescription biosimilars, interchangeable biosimilar products, and their reference listed drugs (RLDs) to ensure that such labeling is accurate and truthful.

Pharmaceutical industry representatives praised the US Food and Drug Administration's (FDA) decision to eliminate the requirement for comparative clinical studies for most biosimilars during a meeting on Wednesday kicking off the reauthorization of FDA's Biosimilar User Fee Amendments (BsUFA) program.

The International Council for Harmonisation (ICH) announced plans to develop two new guidelines on 26 November. One will focus on the use of real-world evidence (RWE) to inform regulatory decision-making, and the other will establish a framework for assessing the utility of comparative efficacy studies in biosimilar development programs. The updates were announced following the ICH Assembly held in Singapore, 18-19 November.

Two of the US Food and Drug Administration's (FDA) top regulators proposed a new approach for approving personalized medicines under a so-called 'plausible mechanism” pathway. The pathway would enable the agency to approve individualized gene therapies and other bespoke medicines in cases where randomized trials are not feasible, and the biological cause of the disease is known.

The US Food and Drug Administration (FDA) has named Richard Pazdur to lead its drug center, just over a week after the departure of its former director, George Tidmarsh, who resigned amid an investigation into his alleged conduct involving a social media post targeting a product made by a company chaired by a former business associate.

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

The US Food and Drug Administration (FDA) announced a streamlined approach to developing biosimilars that could eliminate the need for drugmakers to conduct comparative efficacy studies (CES) to demonstrate biosimilarity to a reference product. Instead, manufacturers would be able to perform comparative analytical assessments (CAAs) to establish the comparability, except in certain cases when a CES is still necessary.

BETHESDA, MD — The US Food and Drug Administration's (FDA) top biosimilar regulator said that a recent report that found lacking biosimilar development to many of the biological products that will soon lose patent protection is a warning sign for the future of drug affordability in the US.

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or subject to a refuse-to-file (RTF) decision, in an updated manual of policies and procedures (MAPP) on Thursday.

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) recently released net hiring data that shows steep job losses at both centers in FY 2025.