FDA announces a temporary six-month program to provide rapid information to stakeholders on regulation of human cells, tissues, and cellular and tissu...
FDA posts a draft guidance on Mouse Embryo Assay for Assisted Reproduction Technology Devices.
Federal Register notice: FDA posts a list of information collections that have been recently approved by OMB.
CDER biotechnology products director Steven Kozlowski says requiring biologics manufacturers to obtain a USP monograph for their products could stifle...
FDA accepts for priority review a Genentech supplemental BLA for Rituxan (rituximab) for combination use with glucocorticoids for treating granulomato...
The HHS Inspector General says 89% of hospitals that use non-patient-specific compounded drugs obtain them from an FDA-registered outsourcing facility...
Federal Register notice: FDA seeks comments on an information collection extension entitled Reporting Associated With Designated New Animal Drugs for ...
FDA clears an Applied BioCode 510(k) to permit the use of Roches MagNA Pure 96 Extraction System with the high throughput BioCode MDx-3000 and Gastroi...