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Federal Register notice: FDA makes available a final guidance entitled Orange Book Questions and Answers.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Failure To Respond to an ANDA Complete Response Letter With...[ Price : $8.95]
Medexus Pharmaceuticals says its medac licensor has resubmitted its NDA for treosulfan, indicated for combination use with fludara...[ Price : $8.95]
Philips discusses proposed terms of a consent decree with FDA involving the companys troubled Respironics unit and its ventilators...[ Price : $8.95]
Medical device maker Biotronik pays $13 million to resolve allegations that it violated the False Claims Act by causing false clai...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Conducting Remote Regulatory Assessments Questions and Ans...[ Price : $8.95]
Federal Register notice: FDA issues an order debarring Kenneth Zipperer for five years from importing or offering for import any d...[ Price : $8.95]
Federal Register proposed rule: FDA proposes to amend its regulations to move to a new format for National Drug Codes.