US Food and Drug Administration regulatory science research is beginning to pay off in generic drug approvals.
Office of Generic Drugs data shows ANDA approvals directly related to research projects conducted through the generic drug user fee...
GDUFA Research Impacting Generic Development, ANDA Approvals
Listen to this article
Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.
Learn what's happening at the US FDA. On the go.
More from Generics
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
• By
Private Company Edition: June’s eight $100m-plus venture capital rounds already outpace the seven each raised in March, April and May, including €255m ($274.2m) for ITM and $200m for Upstream, but while there were five $25m or less VC financings during the past week, mid-sized deals were lacking.
• By
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
More from Biosimilars & Generics
• By
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
• By
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
• By
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.