Regulatory Focus

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week HHS proposed several big measures to accelerate drug development, FDA warned about third-party testing facilities falsifying drug data, and the agency published several reports on the state of the drug industry and clinical trials.

European groups have raised questions about how patient preference studies (PPS) can be adapted from one region to another under the International Council on Harmonization (ICH) E22 guideline. Similar to their counterparts in the US, one major pharma group in the EU expressed the need for caregiver input for these studies. This feedback was in responses submitted by industry groups and manufacturers to the European Medicines Agency (EMA) during its call for comments on the guideline.

The US Food and Drug Administration (FDA) says two marketing videos submitted by Pinnacle Biologics make misleading statements about the company's cancer drug Photofrin (porfimer sodium), noting that the lack of details about the drug's full indication and limitations, especially insufficient statements about its risks, could mislead healthcare providers.

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.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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and drugmakers have written to the US Food and Drug Administration (FDA) to ask the agency to harmonize its recent draft guidance on developing fermentation and semi-synthetic antibiotics with global regulators.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.