[ Price : $8.95]
FDA says it is starting the FDA PreCheck program to help drug companies develop manufacturing facilities in the U.S.[ Price : $8.95]
FDA publishes a draft International Council on Harmonization guideline for extractables and leachables to solicit public comment.[ Price : $8.95]
Former FDAer Julie Tierney is now a principal in Leavitt Partners Washington office.[ Price : $8.95]
FDA issues Johnson & Johnson a complete response letter for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidas...[ Price : $8.95]
FDA approves an Instylla PMA for its Embrace Hydrogel Embolic System, a liquid embolic device for treating hypervascular tumors in...[ Price : $8.95]
FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood gluc...[ Price : $8.95]
FDA issues an online post describing the safety to patients of the type of PFAS used in medical devices.[ Price : $8.95]
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a pot...