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This edition of Quick Notes reviews the regulatory and/or judicial status of four drugs, including an add-on therapy for a rare blood disorder, a drug to treat forms of pulmonary arterial hypertension, a new drug to treat a pediatric metabolic disorder and an IV maintenance drug for patients with early Alzheimer’s disease. Read More
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
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
This edition of Quick Notes reviews Merck’s pulmonary arterial hypertension treatment with Winrevair, a fourth approval for AstraZeneca’s Ultomiris, Akebia approval for Vafseo tablets and another clearance for Neuronetics’ Neurostar device. Read More