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Guest columnists Darius Lakdawalla and Charles Phelps write on the need for a new way to evaluate the value of drugs and therapies. Darius Lakdawalla is the Quintiles Chair in Pharmaceutical Development and Regulatory Innovation at the University of Southern California and cofounder of EntityRisk, and Charles Phelps is a professor at the University of Southern California and provost emeritus of the University of Rochester. Read More
A corporate culture that values quality management at every level is key to achieving and maintaining high-quality data throughout the life cycle of all in vivo bioavailability (BA) and bioequivalence (BE) studies, according to draft FDA guidance on the issue. Read More
Two newly revised FDA policy papers outline how CDER will evaluate Risk Evaluation and Mediation Strategies (REMS) and REMS Assessment Reports. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Three FDA final guidances address electronic submissions for reporting adverse reactions — one for investigational new drug application (IND) safety reports, one for transmitting electronic individual case safety reports (ICSR), another for ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database and a third for expedited ICSRs from certain IND-exempt studies. Read More
The FDA is providing a public list of all approved ANDAs for drugs that received a Competitive Generic Therapy (CGT) designation and will note which ANDAs are for drugs that were also eligible for CGT exclusivity. Read More
As negotiators hash out prices for certain top-selling Medicare Part D drugs, the maximum fair price (MFP) could ultimately be far below the actual value that the drug offers to patients, according to researchers at the Tufts Center for the Study of Drug Development (CSDD). Read More
Over the past week, the FDA published a proposed rule to ban electrical stimulation devices and issued guidance on bioavailability and bioequivalence testing samples. Draft guidance was issued on animal studies for dental bone grafting. Facility fee rates for FY 2024 for the OTC Monograph Drug User Fee program were published. Read More