Akeega (niraparib and abiraterone acetate) Zejula (niraparib) Haemorrhage FDA is evaluating the need for regulatory action. Certain amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate […]

Regulatory science at FDA is the science of developing new tools, standards, and approaches to assess the safety and performance of the products it regulates. CDER’s […]

NDRP Modernization the New Drugs Regulatory Program (NDRP) modernization effort allows CDER support staff in protecting and promoting health by ensuring drugs are safe, effective, and […]

HOST: Captain Mary Kremzner, U.S. Public Health ServicePHARMACIST #1: Commander Jaewon Hong, U.S. Public Health ServicePHARMACIST #2: Lieutenant Commander Beth Carr, U.S. Public Health Service CAPT […]

HOST: Mary KremznerPHARMACIST #1: Beth CarrPHARMACIST #2:  Jaewon Hong MARY: The Food and Drug Administration reviews advertising and promotional labels for prescription drugs to make sure […]

HOST: Captain Mary Kremzner   PHARMACIST: Lieutenant Lindsay Davison Captain Kremzner: The Orange Book has long been a reliable resource for information about FDA-approved drugs. The electronic […]

CAPT Kremzner: What do you do with medications that have not been used or are out of date?  When they are no longer needed, it’s important to […]

Host:  Captain Mary KremznerPharmacist:  Henry Yu, Pharm D. CAPT Kremzner:  The “NDC Directory” locates unique National Drug Codes for marketed products. It’s a quick, easy, online resource.Hi, I’m Captain […]

HOST: Captain Mary KremznerPharmacist: Dr. Kimberly Chiu Captain Kremzner: Drug benefits and risks; today, we’ll learn about the many components of Risk Evaluation and Mitigation Strategies […]