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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
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), unique numbers that capture information about legal business entities and their functions within the supply chain. Read More