On Friday, the FDA issued a draft guidance document intended to provide ANDA holders with information about how and when to propose any necessary labeling updates to their drugs when the reference-listed drug (RLD) upon which...more
On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more