In an effort to improve safety detection, the FDA issued a final rule and draft guidance on 29 September 2010 to clarify the requirements governing safety reporting requirements for human drug and biological products subject to an investigational new drug (IND) application.
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Generics
News
- 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
- Revlimid (lenalidomide) generics launch across Europe
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Biosimilars
News
- EMA recommends approval of eculizumab biosimilar Epysqli
- New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa
- Advances for STADA-Xbrane’s Ximluci in Europe, the UK and the US
- Rinvoq approved to treat Crohn’s disease in Europe
Research
- High mannose glycans in biosimilars and their pharmacokinetic impact
- Biosimilars in Southern European Hospital Markets: barriers and determinants of uptake
- Using infliximab economic evaluations in IBD to inform biosimilar access policies
- Biosimilars and other copies of biological products
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