Archive for March 2024

Comments filed on the FDA’s proposed guidance on potency assurance for cellular and gene therapy (CGT) products reflect the intricacies that set these treatments apart from drug interventions. Source: Drug Industry Daily

Comments are sought by the Scientific Committee on Health, Environmental and Emerging Risks on an update of the European Commission guidelines on the presence of phthalates in medical devices. Source: Drug Industry Daily

Six manufacturers of numbing gels, creams and sprays marketed to relieve pain from cosmetic procedures have received FDA Warning Letters for concentrations of lidocaine in their products in excess of the allowance of 4 percent for OTC topical pain relief products. Source: Drug Industry Daily

The FDA’s guidance on the quantity of bioavailability (BA) and bioequivalence (BE) testing samples to be retained by NDA applicants and contract research organizations (CRO) contains both draft and final language focusing on both the test article and reference standard. Source: Drug Industry Daily

The recruitment and retention of Bioresearch Monitoring (BIMO) program investigators has been a thorn in the side of the FDA that’s negatively impacted trial inspections, a Government Accountability Office (GAO) audit has found. Source: Drug Industry Daily

Closing on May 31, the European Medicines Agency (EMA) has opened a second consultation for its guideline on requirements for investigational advanced therapy medicinal products (ATMP) in clinical trials. Source: Drug Industry Daily

The FDA on Monday announced creation of the new Quantitative Medicine (QM) Center of Excellence to facilitate and coordinate the continuous evolution and consistent application of QM across CDER. Source: Drug Industry Daily

In a step rarely taken by the agency, the FDA today has proposed a ban of electrical stimulation devices (ESD) intended to reduce or stop self-injurious or aggressive behavior because the agency has determined that these devices present an unreasonable and substantial risk of illness or injury. Source: Drug Industry Daily

This edition of Quick Notes looks at the first nonsteroidal oral med for Duchenne muscular dystrophy, expanded indications for a cardiovascular risk reduction drug, an oncology approval, two Complete Response Letters for trial enrollment, and a combo pill for pulmonary hypertension. Source: Drug Industry Daily

A week following the EPA’s announced new rules for facilities emitting cancer-causing ethylene oxide (EtO), FDA officials urged consensus standards be developed and broadly accepted for medical device sterilization protocols and premarket submissions. Source: Drug Industry Daily