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Latest From Brenda Sandburg
Warning letter objects to webpage and meeting exhibit material for excluding any risk information and suggesting mist formulation is superior to oral zolpidem products.
FDA final guidance recommends comparative pharmacodynamic studies for nasal and oral routes of abuse, simplifies statistical approach to show deterrence of generic is same as brand.
A description of the patent challenge proceeding and how it differs from district court litigation.
Supreme Court to consider whether Patent Trial and Appeal Board must address all patent claims challenged in an inter partes review petition.
Biopharma and generic industries stand on opposing sides in case that could eliminate the patent challenge proceeding. Interactive timeline covers IPR's five-year history leading to oral arguments Nov. 27.
Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.