The agency has outlined its Orphan Drug Modernization plan, which it said is part of a larger effort called the Medical Innovation Development plan modernize and make efficient the FDA’s regulatory tools and policies.
The Food and Drug Administration has shared a list of drugs without patents or exclusivity that don't yet have generics, and has outlined a new plan for expediting review of generics of drugs with limited competition.
J M Smith has named Saul Factor — who was most recently EVP corporate strategy at Accord Healthcare and spent 10 years with McKesson’s generics division — to head the pharmacy technology solutions company.
Rituxan Hycela contains hyaluronidase human, an enzyme that helps with the subcutaneous delivery of Rituxan's active ingredient, rituximab, allowing for faster administration compared with intravenous Rituxan.
The Preserving Patient Access to Compounded Medications Act of 2017 would clarify the Drug Quality and Security Act in a way that would align the statute with congressional intent to balance the issues of public safety and patient access.