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Federal Register Notice: FDA releases a draft guidance: entitled How to Obtain a Letter from FDA Stating that Bioequivalence Study...[ Price : $8.95]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]
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]
FDA posts a draft guidance intended to help generic drug sponsors get testing samples from reference-listed drug makers that have ...[ Price : $8.95]
CDER pharmacists Catherine Chew and Lindsay Davison say a new USP naming policy for salt drug substances should help reduce medica...[ Price : $8.95]
FDA deputy commissioner Sally Howard says that while the agency has been slow in issuing guidance for biosimilars, it is reviewing...[ Price : $8.95]
CorMedix, Inc. files an application with FDA seeking Qualified Infectious Disease designation for its Neutrolin Catheter Lock solu...