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CDRH says it will complete a safety review of Bayer Healths controversial Essure permanent birth control device by the end of Febr...[ Price : $8.95]
New York University law professor Catherine Sharkey describes two recent court cases that explore the tension between federal and ...[ Price : $8.95]
Five PDUFA 6 Reauthorization Steering Committee sub-groups report on their discussions and progress at the 10/20 steering committe...[ Price : $8.95]
Four Quarles & Brady attorneys summarize provisions of a new FDA guidance on institutional review board minutes.[ Price : $8.95]
FDA warns Sandoz Private Limited about CGMP problems found at two drug manufacturing facilities in India.[ Price : $8.95]
U.S. senator Lisa Murkowski (R-AK) says she will oppose Robert Califfs nomination to become the next FDA commissioner due to the a...[ Price : $8.95]
FDA releases its 11/5 Warning Letter to Dr. Reddys Laboratories detailing findings from inspections at three of the companys facil...[ Price : $8.95]
FDA posts a draft guidance on Certification Process for Designated Medical Gases that explains how the agency administers the cert...