Tissue Agnostic Drug Development in Oncology (Draft)-2022/10/17

Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment (Final)-2022/10/17

Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials (Draft)-2022/10/17

ANDA Submissions – Prior Approval Supplements Under GDUFA (Final)-2022/10/14

Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (Final)-2022/10/13

Competitive Generic Therapies (Final)-2022/10/5

Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry (Final)-2022/10/5

Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry (Final)-2022/10/5

Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments (Final)-2022/10/5

User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications (Final)-2022/10/5