Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’
The next director of the US Food and Drug Administration’s Office of Generic Drugs must be prepared to have “frank conversations” with colleagues, as well as sponsors and other stakeholders, to ensure the wide-ranging program runs smoothly, former OGD Director Kathleen Uhl said.
FDA officials are beginning what is expected to be a national search for a new OGD director following the 26...
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.
