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FDA issues guidances to help sponsors develop drugs intended to treat three types of bacterial pneumonia.[ Price : $8.95]
FDA says Home Care Pharmacy of Palm Coast violated regulations involving compounded drug products and adulterated drugs.[ Price : $8.95]
FDA grants preCardia, Inc., a breakthrough device designation for its catheter-based system for treating volume overload in patien...[ Price : $8.95]
FDA says healthcare providers should continue to use coronavirus antibody tests to help identify people who have been exposed to t...[ Price : $8.95]
FDA lifts a partial clinical hold against an Innate Pharma Phase 2 clinical trial (TELLOMAK) that is evaluating the efficacy and s...[ Price : $8.95]
CBER updates its list of guidance documents it plans to issue in 2020, noting that 16 of the 28 earlier proposed documents have al...[ Price : $8.95]
FDA says it has qualified INSPIRE questionnaires through the medical device development tool program to assess the impact of autom...[ Price : $8.95]
Public Citizen asks FDA for a Boxed Warning and other labeling changes for several drugs approved for Type 2 diabetes to indicate ...