[ Price : $8.95]
FDA sends untitled letters to four companies indicating they need BLAs if they are to lawfully market amnion/chorion products as d...[ Price : $8.95]
CDRH publishes a revised standard operating procedure for providing Notice to Industry letters on new Center expectations.[ Price : $8.95]
Two organizations and an individual raise questions and offer suggestions for an FDA strategic plan on communicating health-relate...[ Price : $8.95]
Federal Register Correction: FDA corrects introductory text on the presence of mandatory label information and the definition of a...[ Price : $8.95]
Federal Register Notice: FDA announces the user fee rate for using a tropical disease priority review voucher for fiscal year (FY)...[ Price : $8.95]
Federal Register Notice: CDRH releases the draft standard operating procedure for Level 1, Immediately in Effect guidance document...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Tobacco Retailer Training Programs.[ Price : $8.95]
FDA clears America Stem Cell, Inc. to begin a Phase 1/2a dual umbilical cord transplantation study of ASC-101 in patients with hem...