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The U.S. Food and Drug Administration (FDA) is seeking public feedback on whether its scale-up and post-approval changes (SUPAC) guidance documents for the pharmaceutical industry need to be updated and modernized.

Senators and expert witnesses voiced concerns about the US Food and Drug Administration's (FDA) oversight of rare disease therapies during a hearing of the Senate Special Committee on Aging on Thursday. These concerns included claims of inconsistent review processes, the agency's failure to apply regulatory flexibility, and the issuance of nearly two dozen complete response letters (CRLs) for rare disease treatments since the start of 2025.

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has published a new guidance agenda that outlines the guidance it plans to release this year, including both new and revised guidance documents. This latest agenda features several additions to the agency's list.

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.

BETHESDA, MD – The pharmaceutical industry and the US Food and Drug Administration (FDA) are collaborating on a structured data platform for submitting chemistry, manufacturing, and controls (CMC) information in new drug applications. This initiative is part of Project PRISM, which is the FDA's regulatory cloud submissions platform.

The European Medicines Agency (EMA) has released a guideline on assessing the quality of inhaled and nasal medicines, as well as a guideline on demonstrating therapeutic equivalence (TE) of orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disorder. Both guidelines will take effect on February 1.

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.

The Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation on plans to extend the abbreviated procedure for new medicine applications and certain change notifications.

The US Food and Drug Administration (FDA) has announced it will take a flexible approach to reviewing all new cell and gene therapy (CGTs) biologics license applications (BLAs) to expedite the development of these products, rather than applying its flexibilities on a case-by-case basis.

The US Food and Drug Administration (FDA) issued a draft guidance on Friday to assist sponsors in using Bayesian methods to support the safety and effectiveness of new drugs in clinical trials. These methods utilize information from previous studies to accelerate the drug development process.

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.

The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit 'cross-center” master files (MFs) that are referenced and intended to support more than one regulatory submission. The guidance applies to combination products and non-combination products.

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing practices (cGMPs), which included issues related to data integrity.

Numerous pharmaceutical industry groups are advocating for the expansion of the US Food and Drug Administration's (FDA) PreCheck program to cover existing manufacturing facilities, as well as new ones. Additionally, some groups recommend that PreCheck be integrated with current programs. The generic drug industry has also suggested that other government initiatives and support should be implemented to strengthen this sector.

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.

During a public meeting on onshoring the production of drugs in the US on Tuesday, stakeholders called for improvements to the US Food and Drug Administration's (FDA) recently launched PreCheck program. They suggested that the program be expanded to include existing facilities, in addition to new ones, and hailed the program for offering a chance at early feedback on manufacturing issues from the agency.

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.