The US Food and Drug Administration (FDA) has implemented a modernized approach to ensure the safety and quality of globally produced innovator and generic medicines. Through its Program Alignment, FDA’s Office of Regulatory Affairs has modernized its workforce and approach to improving public health to keep up with globalization and increasingly complex supply chains. Since FDA implemented Program Alignment in 2017, the regulation of generic medicines has become increasingly strategic, risk-based and efficient.
- INICIO
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Genéricos
Novedades
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Investigación
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
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Biosimilares
Novedades
- La FDA aprueba el biosimilar intercambiable de adalimumab Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
- FDA BLA updates from Celltrion and Accord
- FDA approves pegfilgrastim biosimilar Udenyca OnBody autoinjector
Investigación
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
- Switches between biosimilars and their reference products
- Latin America's biosimilars market: regulatory, institutional, and technological aspects
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