Commentary: Gary Wolensky, Esq.

Law360, July 29, 2016

Litigation attorney, Gary Wolensky, comments on the FDA’s proposed policy which would allow generic-drug makers to update safety labels detailing new risks without approval. Currently, brand-name drug makers can update labels without seeking approval in regards to new safety information, but generic-drug makers must wait for the FDA to direct them to do so. The final rule of the policy has been delayed until April 2017 and will wait for the new administration to issue the final rule.