Joanne S. Eglovitch

The US Food and Drug Administration (FDA) recently warned an over-the-counter (OTC) drugmaker citing the failures to conduct raw materials and release testing for its fluoride toothpaste tablets. In a separate compliance action, the agency warned a clinical investigator for failing to ensure that study drugs were administered to pediatric patients according to the clinical investigation plan. Both warning letters were posted to FDA@s website on 3 September. @

The use of surrogate markers to support drug approvals without requiring postmarketing studies can @hinder accurate and informed decision-making by patients and clinicians,@ according to a recent study published in JAMA. @

The US Food and Drug Administration (FDA) on Wednesday issued a revised final guidance to assist manufacturers in detecting and controlling nitrosamine impurities in pharmaceutical products. @

The World Health Organization (WHO) has finalized its first-ever guidance to limit waste from antibiotic manufacturing facilities in an effort to address antimicrobial resistance (AMR). @

Pragmatic clinical trials (PCTs) offer a promising alternative to explanatory trials, according to a recent commentary published in the ESMOReal World Data and Digital Oncology. Such trials feature simplified study protocols and data collection methods and enable a wider patient selection pool, which the authors believe can enhance clinical research. @

The European Medicines Agency (EMA) on 9 September proposes updating its guideline on developing drugs for treating bipolar disorder (BD) to reflect new medical understanding of the disease. @

Stakeholders want the US Food and Drug Administration (FDA) to provide more clarity on its expectations for use-related risk analyses (URRA) for @stand-alone@ non-combination medical products. They also called for more alignment with the agency@s human factors guidance and ISO standards. @

The US Food and Drug Administration (FDA) on Wednesday released a draft of its strategic plan to promote the uptake of innovative manufacturing technologies for drugs and biologics.

The US Food and Drug Administration (FDA) on Thursday issued updated guidance on the classification of amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) that reflects the recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III).

LONG BEACH, CA @ Andrea Laslop, head of the scientific office at the Austrian Medicines and Medical Devices Agency (AGES), said that seeking scientific advice from regulators on innovative products is a @well-defined and established process@ and that such advice can be requested on any issue related to developing these products.