Submissions and Approvals

FDA Approves Second Gene Therapy

The FDA approved a second gene therapy for cancer, adding Kite Pharma’s lymphoma treatment Yescarta (axicabtagene ciloleucel) to the fledgling list. Read More

FDA Guidance Lays Out Requirements for ANDA Post-CRL Meetings

The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to raise and the people who will participate in the meeting and includes other items spelled out by the agency in draft guidance, the FDA said. Read More

FDA Outlines ANDA Reconsideration Procedures

The FDA has formalized its guidelines for sponsors seeking reconsideration of scientific or regulatory issues early in the approval process for generic drugs, issuing a guidance that also affirms the agency’s response-time pledges. Read More