Regulatory Focus

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has issued a guidance to assist sponsors in assessing potency assays for active immunotherapy products (ACTIMPs), including cancer vaccines and treatments for autoimmune diseases.

The US Food and Drug Administration (FDA) recently sent warning letters to companies in China, India, and the US for multiple violations of good manufacturing practices (GMP) related to the production of active pharmaceutical ingredients (APIs) and finished drugs.

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The US Food and Drug Administration (FDA) is seeking feedback on a competency-based approach to regulating medical devices that utilize generative artificial intelligence (GenAI).

The US Food and Drug Administration (FDA) on Monday finalized guidance on its approach to making therapeutic equivalence (TE) evaluations and assigning therapeutic equivalence (TE) codes for abbreviated new drug applications (ANDAs). These codes are listed in the agency’s Orange Book and denote a drug’s bioequivalence to a reference-listed drug (RLD).

Australia’s Therapeutic Goods Administration (TGA) has started a consultation into proposed changes to support automated decision making (ADM) for listed medicine variation applications.

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The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to the development of cellular and gene therapy (CGT) products.