The US Food and Drug Administration (FDA) announced on 18 October 2018 that it has proposed to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to advance the harmonization of scientific and technical standards for generics.
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Generics
News
- 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
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
News
- EC approves eight biosimilars, six more await final authorization
- EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma
- FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo
- Canada approves pegfilgrastim biosimilar Pexegra
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