Regulatory Focus

The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. However, they have requested clarification on several points, including off-target data, nomination methods, and additional information on how to assess these products following any manufacturing changes.

The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the high costs associated with fully publicizing a drug's safety profile and practical limitations of broadcast advertising, according to experts who spoke to Focus. It could also make such ads hard to understand for many consumers.

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.