Recently, the Food and Drug Administration proposed amending its regulations in connection with drug labels to revise and clarify procedures for an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA’s review of the change.
The basic rule would allow holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a ‘‘changes being effected’’ (CBE–0) supplement.
Furthermore, the propsed rule would also amend the regulations to allow submission of a CBE–0 labeling supplement for certain changes to the ‘‘Highlights of Prescribing Information’’ for drug products with labeling in the ‘‘Physician Labeling Rule’’ (PLR) format.
Essentially, the rule would allow for parity among the NDA drug application holder and the ANDA drug application holder when it comes to informing everyone about potential changes to the drug label.
In other words, if this proposed rule becomes an FDA regulation, a generic drug application holder may – when it becomes aware of a change to the brand drug’s label, distribute a revised label without waiting for the brand drug application holder to revise the label.
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