Drug Sponsor Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abametapir – Xeglyze HATCHTECH PTY LTD Medical (PDF – 4 MB) Addendum (PDF […]

Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. The Center for Drug Evaluation […]

FDA provides information to assist industry in the development of generic drugs and submission of abbreviated new drug applications (ANDAs). This section includes links to summary […]

Potential ANDA applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and application preparation processes. If you […]

The results of our science and research often provide the generic drug industry with new methodologies and tools to help establish drug equivalence standards and support […]

For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease […]

For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Who We Are   The Office of Program and Regulatory Operations (OPRO) provides expertise in leading and managing compliance projects, by utilizing innovative and efficient project management […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]