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The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls (CMC) flexibilities for cell and gene therapy (CGT) products developed for biologics license applications (BLAs).

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.