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Two pharmaceutical associations suggest ways to clarify an International Council on Harmonization draft guidance on evaluating the...[ Price : $8.95]
Federal Register notice: FDA issues an order permanently debarring Gabriel J. Letizia, Jr from providing services related to an ap...[ Price : $8.95]
Federal Register notice: FDA determines that Mallinckrodts Ofirmev (acetaminophen) injection, 1,000 mg/100 ml, was not withdrawn f...[ Price : $8.95]
FDA denies a citizen petition from advocacy group Public Citizen that urged it and the Drug Enforcement Administration to open pro...[ Price : $8.95]
Merck says it has identified the root cause of nitrosamine formation in certain Januvia (sitagliptin) batches.[ Price : $8.95]
Federal Register notice: FDA classifies prognostic tests for assessing liver-related disease progression into Class 2 (special con...[ Price : $8.95]
The HHS Inspector General says FDA has concurred with recommendations on steps to improve its management of IT acquisition contrac...[ Price : $8.95]
Two CDER officials describe work being done under the Biosimilar User Fee Amendments 3.