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- FDA releases proposed commitment letter detailing changes to GDUFA IV programThe U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV). The letter follows several months o…
- Vaccine makers say splitting MMR vaccine is impractical despite presidential directiveVaccine manufacturers responded to a recent order from President Donald Trump to separate the combined measles, mumps and rubella (MMR) vaccine, noting that while the concept is theoretically possi…