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The FDA on Friday issued a new draft guidance that would formalize its current process for issuing discretionary Certificates of Confidentiality for commercial sponsors that seek to prohibit disclosure of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
The House Judiciary Committee voted unanimously in a Wednesday evening markup hearing to advance two bills that crack down on anticompetitive patent tactics wielded by drugmakers. Read More
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in draft guidance released Wednesday. Read More