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A Brookings Institution report says FDA and the Centers for Medicare and Medicaid Services should run a health sector-wide pilot p...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: entitled How to Obtain a Letter from FDA Stating that Bioequivalence Study...[ Price : $8.95]
Federal Register Notice: FDA withdraws approval of 23 NDAs and 68 ANDAs that are no longer marketed.[ Price : $8.95]
A Wiley Rein client alert opines on a recent draft guidance offering generic drug sponsors one means to get testing samples from r...[ Price : $8.95]
FDA tentatively approves two Mylan NDAs for two dosages of abacavir/lamivudine tablets for oral suspension for treating HIV-1 infe...[ Price : $8.95]
Heart Sync begins a device correction for certain multi-function defibrillation electrodes due to connector compatibility issue wi...[ Price : $8.95]
The Senate approves unanimously legislation adding Ebola as a qualifying disease for the FDA priority review voucher program.[ Price : $8.95]
Three FDAers make the case for randomized, controlled trials rather than an historical control in evaluating potential Ebola thera...