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Federal Register notice: FDA makes available a guidance entitled Real-Time Oncology Review (RTOR).[ Price : $8.95]
FDA releases the form FDA-483 with 14 observations from an inspection at the Kilitch Healthcare India sterile drug manufacturing f...[ Price : $8.95]
Federal Register notice: FDA proposes to withdraw approval of Phibro Animal Healths NADAs for carbadox in medicated swine feed.[ Price : $8.95]
The International Society for Cell & Gene Therapy suggests ways to improve an FDA draft guidance on manufacturing changes and comp...[ Price : $8.95]
In a major move against questionable drug patents, the FTC challenges the legitimacy of more than 100 patents listed in FDAs Orang...[ Price : $8.95]
Two Hyman, Phelps & McNamara staff say FDA missed an opportunity to conduct many remote interactive evaluations of drug manufactur...[ Price : $8.95]
FDA warns Irvine, CA-based Neurotris about multiple violations in its illegal manufacturing and distribution of muscle stimulator ...[ Price : $8.95]
FDA publishes a guidance with recommendations for select NDAs and BLAs submitted for Real-Time Oncology Review.