On Friday, the FDA issued a draft guidance document intended to provide ANDA holders with information about how and when to propose any necessary labeling updates to their drugs when the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
On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more