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Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any new framework for repurposing drugs does not disincentivize investment or competition and fits within agency’s existing statutory authority.

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new topics since the list was last updated in February.

The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.

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The acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official agency policy or guidance.

Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry offers improvements over the current program while addressing the agency’s resource constraints.

The US Food and Drug Administration (FDA) recently issued two warning letters to a sterile drug manufacturer and an over-the-counter (OTC) drug maker in the US for multiple violations of good manufacturing practices (GMPs). These violations included inadequate contamination controls, failure to investigate batch issues, and insufficient testing of components.

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The US Food and Drug Administration (FDA) on Monday released final guidance detailing the procedures for holding formal meetings between sponsors of over-the-counter (OTC) monograph drugs and the agency. This update revises the criteria for the types of meetings that sponsors can request and introduces hybrid meetings as an additional option for consultations with FDA.

The US Food and Drug Administration (FDA) has finalized its guidance on clinical trial requirements for developing psychedelic therapies. The final version clarifies the agency's thinking, based on industry feedback, especially regarding clinical and safety considerations in the design of clinical trials.