Regulatory Focus

The US Food and Drug Administration (FDA) roadmap to reduce animal testing as a requirement for drug development has already made an impact after its first year, but the initiative faces future challenges in scaling and international harmonization, a group of experts wrote in a recent paper published in Stem Cell Research & Therapy.

The European Parliament has called for the temporary suspension of plans to make drugmakers pay for wastewater treatment.

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PHILADELPHIA – Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of clinical investigators or sponsors receiving a Form 483 following a bioresearch monitoring inspection.

Several industry groups and drugmakers have written to the US Food and Drug Administration (FDA) to ask the agency to harmonize its recent draft guidance on developing fermentation and semi-synthetic antibiotics with global regulators. They also said the guidance lacked significant detail and asked the agency to harmonize terminologies.

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for investigational new drug (IND) submissions to FDA.

The US Food and Drug Administration (FDA) has cited several online companies, including retail giant Amazon, for selling products that have not been evaluated for safety and efficacy by regulators. It also warned a couple of drugmakers for failing to meet its current good manufacturing practices (CGMP) requirements, including falsifying laboratory testing data.

PHILADELPHIA – Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased international collaboration is influencing the development of policies about artificial intelligence during the Drug Information Association's (DIA) Global Annual Meeting last week.