The US FDA is authorised to perform inspections under the Federal Food, Drug, and Cosmetic Act. The FDA Form 483 is a form used by the FDA to document and communicate concerns discovered during these inspections and to list items that deviate from Good Manufacturing Practices.
- INICIO
-
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
-
Biosimilares
Novedades
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
- EMA recommends approval of ustekinumab biosimilar Pyzchiva
- La FDA aprueba el biosimilar intercambiable de adalimumab Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
Investigación
- Cuestionando la necesidad de evaluaciones de sensibilidad étnica para anticuerpos monoclonales biosimilares
- ANVISA's role in biosimilar medicine regulation and innovation promotion
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
- MORE EDITORIAL SECTIONS
- Search
Comments (1)
Post your comment