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Federal Register Notice: FDA reopens the comment on a draft guidance on 510(k) device modifications.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites International Isotopes and SterilMed.[ Price : $8.95]
Recently retired CDRH Office of Compliance director Tim Ulatowski joins Becker & Associates Consulting in the firms Washington, DC...[ Price : $8.95]
FDA and NephroGenex reach agreement on the design of a new Phase 3 Subpart H (accelerated approval) program that evaluates Pyridor...[ Price : $8.95]
The Tufts Center for the Study of Drug Development says that the number of monoclonal antibodies in clinical study has been steadi...[ Price : $8.95]
An Institute of Medicine report says that FDA may have to regulate health IT safety if the private and public sectors cant make su...[ Price : $8.95]
FDA says it is analyzing compounded hydroxyprogesterone caproate products and the bulk APIs used to make them.[ Price : $8.95]
FDAs Seattle District Office warns International Isotopes about CGMP problems in manufacturing a radiopharmaceutical and marketing...