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June 25, 2018
GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.
June 22, 2018
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
The approval is intended to increase patient access to treatment for opioid addiction.
FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
June 21, 2018
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
June 20, 2018
Legislators have requested that FDA do more to prevent drug shortages.
June 14, 2018
FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.
June 08, 2018
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
June 07, 2018
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
June 05, 2018
The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.