FDA Announces Availability of the Guidance, "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format" FDA CDER Announces Availability of Updated Question-based Review MaPP
FDA Approves EPCLUSA® (Sofosbuvir and Velpatasvir) FDA Announces Availability of the Draft Guidance, "Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product"
FDA Determines Multiple Comparison Procedure-Modeling (MCP-Mod) Statistical Approach is Fit-for-Purpose FDA Approves NUPLAZID® (Pimavanserin)
FDA Warns About Serious Life-Threatening Arrhythmias With High Doses of the Antidiarrheal Medicine Loperamide (Imodium), Including From Abuse and Misuse
FDA Approves NETSPOT® The FDA’s Office of Clinical Pharmacology Staff Participate in Expert Working Groups Developing White Papers for Improving the Tools and Methods That Underpin the Development of Innovative Drugs to Treat a Variety of Diseases and Conditions FDA Approves AXUMIN™ FDA Approves TALTZ® FDA Approves VENCLEXTA™ FDA Approves ANTHIM® FDA Approves DEFITELIO® FDA Approves ZEPATIER® FDA Approves BRIDION® FDA Approves Genoya® FDA Approves NINLARO® FDA Approves NUCALA® FDA Approves ONIVYDE™ FDA Conducts Analysis to Assess Acceptability of Extrapolation of Antiepileptic Drug