The US Food and Drug Administration (FDA) Office of Generic Drugs 2019 Annual report gave updates on the number of generics approvals in 2019. These remained high at 1,014 [1-3]. The report also discussed the progress of the FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme , and information about the achievements of the Office of Generic Drugs (OGD) in terms of research proposals, outreach activities and international development.
- 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
- Pricing and reimbursement of medicines in Canada
- Medicines pricing conditions in Italy and Brazil: comparison of regulations
- Relevance of NTI to the treatment of epilepsy
- What is the meaning of a narrow therapeutic index?
- EC approves bevacizumab biosimilar Vegzelma
- FDA accepts application for high concentration adalimumab biosimilar
- EC approves ranibizumab biosimilar Ranivisio
- Applications for natalizumab biosimilars accepted by FDA and EMA
- Recommendations to address challenges to biosimilars in Latin America
- Regulatory landscape for biosimilars in Latin America
- Totality of evidence for biosimilar pegfilgrastim Ziextenzo
- What does the designation of interchangeability for biosimilars in the US mean?
- MORE EDITORIAL SECTIONS