The FDA announced a 23 percent increase in the OTC Monograph Drug User Fee Program (OMUFA) facility fee rates for FY 2024. Source: Drug Industry Daily

The FDA and U.S. Customs and Border Protection (CBP) are partnering to promote supply chain traceability and improve the government’s visibility into imports by focusing on Global Business Identifiers (GBI),…

AstraZeneca has sued to block an Arkansas law that requires the company to ship its drugs to any pharmacy — for-profit or otherwise — working with hospitals participating in the…

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…

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:…

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 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…

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)…

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:…

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:…