Regulatory Affairs

House Members Join Probe in Allergan-Mohawk Patent Deal

Republicans and Democrats on the House Oversight Committee pressed Allergan for an explanation of its decision to transfer patents for its lucrative dry-eye drug Restasis to a Mohawk tribe to protect them from challenges by would-be generic competitors. Read More

Expert Lists Data Integrity Red Flags for Drug Sponsors

Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at the RAPS’ 2017 Regulatory Convergence meeting. Read More