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Federal Register notice: FDA withdraws the approval of 12 NDAs from multiple applicants because they are no longer marketed.[ Price : $8.95]
The HHS Inspector General raises concerns about three of 24 drugs approved through the FDA accelerated approval pathway.[ Price : $8.95]
FDA says a new method of determining an acceptable intake limit for nitrosamine impurities in drugs that it helped to develop has ...[ Price : $8.95]
The Association for Accessible Medicines calls on FDA to produce several guidances for generic oligonucleotide drugs.[ Price : $8.95]
FDA accepts for review an Eisai BLA for Leqembi (lecanemab-irmb) subcutaneous autoinjector weekly maintenance dosing for treating ...[ Price : $8.95]
FDA clears an Icotec 510(K) for the use of its BlackArmor carbon/PEEK implants for treating de novo spinal infections.[ Price : $8.95]
FDA awards Spear Bio a breakthrough device designation for its pTau 217 blood test for early diagnosis of Alzheimers disease.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled Generic Drug User Fee Program to allow ...