Over the past week, the FDA issued final guidances on nonclinical evaluation of the immunotoxic potential of pharmaceuticals, drug-drug interaction assessment for therapeutic proteins and cover letter attachments for controlled…
The FDA sketched out how it is implementing the fee structure of the Generic Drug User Fee Amendments of 2022 (GDUFA III) in a final guidance released Friday. Source: Drug…
The FDA should be as willing to withdraw an accelerated approval as to grant it, write a team of researchers, arguing for a balance between speed and certainty. Source: Drug…
The FDA’s Antimicrobial Drugs Advisory Committee, meeting Thursday, was overwhelmingly positive in its assessment of benefits and risks of AstraZeneca’s respiratory syncytial virus (RSV) preventive treatment, nirsevimab, for children. Source:…
The FDA has finalized its guidance on drug-drug interaction (DDI) studies of investigational drugs with combined oral contraceptives (COC), outlining when these studies are and aren’t needed, how to design…
Eli Lilly has filed an appeal to the U.S. Court of Appeals for the Seventh Circuit following a May 9 decision that it violated the False Claims Act by underpaying…
The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the…
New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and…
Eisai’s Leqembi and AstraZeneca’s nirsevimab are both poised for a greenlight from the FDA if agency briefing documents prepared for two advisory committee meetings this week are any indication. Source:…
iRhythm Technologies’ mislabeling of a cardiac monitor and its component software as well as failure to report serious adverse events, including two deaths, netted the devicemaker an FDA warning in…