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Five stakeholders raise concerns about an FDA draft guidance on when a new 510(k) should be submitted for a change to an existing ...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Innovative Compounding Pharmacy and Valeant Pharmaceuticals.[ Price : $8.95]
Federal Register Final Rule: FDA issues a final rule to amend the regulations to reflect organization change in the agency and to ...[ Price : $8.95]
Federal Register Notice: FDA establishes a public docket to collect comments related to a proposed Study Data Standardization Plan...[ Price : $8.95]
FDA places a clinical hold on a BioInvent International Phase 2 study of the antibody BI-505 in patients with multiple myeloma.[ Price : $8.95]
FDA posts a guidance on Non-Inferiority Clinical Trials to Establish Effectiveness that discusses the appropriate use of such stud...[ Price : $8.95]
FDA clears an EOS Imaging 510(k) to market the kneeEOS software, an online 3D planning product software that uses weight-bearing 3...[ Price : $8.95]
FDA approves an Amgen supplemental BLA for the expanded use of Enbrel (etanercept) to treat pediatric patients (ages 4-17) with ch...