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The European Medicines Agency (EMA) has finalized updated guidance on the information required for the manufacture and control of active substances used in medicinal products, with a 1 September date of application.

Amid discussions to reauthorize the US Food and Drug Administration's (FDA) Prescription Drug User Fee Act (PDUFA VIII) program on 19 February, industry representatives questioned increased PDUFA payroll spending in FY 2025 – despite staff cuts that year – and both sides reached agreement on continuing the Rare Disease Endpoint (RDEA) program.

Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug User Fee Amendments (GDUFA) program. The topics addressed during the meeting included drug master files (DMFs), internal consultations, and imminent actions.

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's (EMA) Network Data Steering Group (NDSG) on Monday released a joint workplan outlining a strategy for leveraging artificial intelligence (AI) and big data over the next two years to expedite the approval of new medicines.

The medical device industry has expressed concerns about the US Food and Drug Administration's revised proposals for resource allocations and enrollment for the Total Product Lifecycle (TAP) program 2.0 program as part of the negotiations for the Medical Device User Fee Amendments VI (MDUFA). Industry also supported extending benefits beyond enrolled products.

Pharmaceutical companies and EU industry groups pushed back against the expectation for sponsors to justify their choice to use adaptive clinical trial designs in the International Council on Harmonisation's E20 guidance on adaptive clinical trials in comments submitted to the European Medicines Agency (EMA).

Medical device industry groups are proposing changes to the US Food and Drug Administration's (FDA) de novo and its pre-submission programs to improve their efficiency. Additionally, these groups are seeking more information about how the agency plans to use user fees to fund its real-world evidence (RWE) program. They are specifically requesting details regarding the full-time equivalents (FTEs) involved in this initiative.

Drugmakers should establish 'sustainable compliance practices” based on a strong quality culture, rather than simply doing the minimum required to pass inspections to avoid receiving a Form 483 or warning letter, said Donald Ashley, principal for regulatory compliance at Eliquent Life Sciences, during a webinar sponsored by the Food and Drug Law Institute (FDLI) on Wednesday.

The US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has updated two internal policy guides for its staff. The first guide outlines the procedures for processing and reviewing investigational new drug applications (INDs), while the second details the procedures for handling clinical holds for INDs.

The International Council for Harmonisation's (ICH) Cell and Gene Therapy Discussion Group (CGTDG) recently released a discussion paper recommending a more tailored approach in its guidelines for cell and gene therapy products. ICH said the updated approach would better reflect the unique characteristics of these products in comparison to traditional drugs.

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 US Food and Drug Administration (FDA) has selected nine companies to participate in the recently announced Commissioner's National Priority Voucher (CNPV) pilot program. As part of the program, the companies will undergo an expedited review process that will last between one to two months.

Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe's largest medical device trade group, MedTech Europe, said there are fundamental issues within both regulations that can only be addressed through substantial improvements.

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is seeking input on methods for assessing and evaluating AI-enabled medical devices in a newly released discussion paper. This includes strategies for identifying and addressing performance drift, which involves detecting changes in both input and output.

WASHINGTON – Denise Gavin, the director of the Office of Gene Therapy at the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), emphasized that clinical teams and chemistry, manufacturing, and controls (CMC) staff need to work closely to accelerate the development of cell and gene therapy (CGT) products.

The Office of Management and Budget (OMB) released the Spring 2025 regulatory agenda on Thursday, laying out the planned proposed and final rules the federal government plans to issue.

The US Food and Drug Administration (FDA) on Thursday announced it will publish complete response letters (CRLs) detailing the reasons for a product's rejection soon after they are issued to drugmakers. Alongside the announcement, the agency released a batch of 89 CRLs for products that have been rejected since 2024 and are no longer being pursued by their sponsors.

Officials from two global registries for rare pediatric cancers expressed a desire for more guidance from the US Food and Drug Administration (FDA) on its expectations for such registries.