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Guidance for Industry Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication of the Federal Register notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857 Moredosage forms), and manufacturing/control aspects specific to radiopharmaceuticals. FDA expects appropriate CGMPs to be applied to all steps of an API ... Less
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