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CDER has developed a new adaptive crossover trial design that can be used in demonstrating the bioequivalence (BE) of generic versions of drugs with high pharmacokinetic (PK) variability. Read More
A newly published Q&A document from the FDA and the European Medicines Agency (EMA) outlines the similarities — and differences — in the two agencies’ requirements for manufacturing breakthrough products. Read More
In a final guidance issued this week, the FDA outlines recommendations for continued development of monoclonal antibody products targeting SARS-CoV-2 to meet emergency needs. Read More
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published an AI workplan intended to create a collaborative and coordinated strategy that will maximize AI’s benefits while managing the risks. Read More
Despite overall industry support for the FDA’s development of a voluntary Quality Management Maturity (QMM) program for establishments manufacturing drugs, stakeholders raised concerns about a lack of details and the level of transparency of report findings. Read More
The Biden Administration wants to investigate how private equity and other corporations’ increasing power and control of the health care system is affecting Americans. Read More
By listening to the experiences and concerns of patients with rare diseases, the FDA can get a better picture of the most troublesome symptoms. Read More
The FDA’s guidance on showing effectiveness through a single trial plus confirmatory evidence is off to a good start in offering direction on leveraging real-world data (RWD), but providing more specifics would be highly beneficial, industry comments say as comments close on the agency’s draft guidance. Read More