[ Price : $8.95]
Federal Register Notice: FDA corrects a docket number in a notice on fees for using a rare pediatric disease priority review vouch...[ Price : $8.95]
Federal Register Notice: FDAs Gastroenterology and Urology Devices Panel will meet 11/18-19 to discuss a heart organ care system a...[ Price : $8.95]
An investigation by FDAs Office of Criminal Investigations leads to an indictment of Nathan Baum of Greenbush, NY, for tampering w...[ Price : $8.95]
FDA posts a guidance on the Integrated Summary of Effectiveness, which recommends the content of such sections in NDAs and BLAs.[ Price : $8.95]
After 22 years of service, CBER director Karen Midthun announces her intention to retire at the end of the year.[ Price : $8.95]
FDA issues a guidance with its current thinking on submitting adverse event reports from drug outsourcing facilities.[ Price : $8.95]
FDAs Denver District Office warns International Medical Development Corp. that it is manufacturing adulterated and misbranded Gert...[ Price : $8.95]
FDA denies an Otsuka petition asking that approval for Alkermes Aristada be delayed or rejected.