The US Food and Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP) which outlines how the Office of Generic Drugs (OGD) will process requests to transfer ownership of generic drug applications, and how it will update the Orange Book to reflect those changes.
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Generics
News
- 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
- Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP
Research
- Re-evaluation of the use of generics, especially when treating conditions such as epilepsy
- Repurposing generic drugs can save time and money
- Availability of medicines and the sustainable development of the national health system in Russia
- Generic etoricoxib is equivalent to the reference drug
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Biosimilars
News
- New adalimumab biosimilars prepare to launch in Canada, US and Europe
- FDA approves Amneal’s bevacizumab biosimilar
- Europe: positive opinion for Inpremzia and Truvelog Mix 30 and Stimufend authorized
- FDA approves Kashiv Biosciences’ filgrastim biosimilar
Research
- Innovent and Eli Lilly announce final results for sintilimab plus biosimilar bevacizumab injection
- Biosimilar adoption and prescribing in Japan: a physician opinion survey
- Totality of evidence supporting approval of Avsola in the treatment of IBD
- Survey results of biosimilars use among Spanish physicians and pharmacists
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