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The FDA hit Florida stem-cell supplier RichSource Stem Cells with an untitled letter for unapproved claims relating to its RICHGEN stem cell product.
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The FDA on Friday issued a new draft guidance that would formalize its current process for issuing discretionary Certificates of Confidentiality for commercial sponsors that seek to prohibit disclosure of identifiable information about a research participant. Read More
Five former FDA Commissioners threw their support behind Stephen Hahn to lead the agency, in a letter to Senate leaders urging his confirmation. Read More
Apicore Pharmaceutical petitioned the FDA to require that any ANDA for Penicillamine capsules should use a specific method to show bioequivalence. Read More