Adjustments to the complex generic drug approval process are growing into an integral part of efforts to bring down drug prices.
While the idea has been mentioned on a number of occasions by FDA and industry officials in the context of...
Document that appears to be fueling upcoming executive order includes ideas for relaxing FDA standards for complex generic approval, which may be one way of creating pressure to lower prices.

Adjustments to the complex generic drug approval process are growing into an integral part of efforts to bring down drug prices.
While the idea has been mentioned on a number of occasions by FDA and industry officials in the context of...
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.
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.
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.
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.
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.
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.