September 25, 2024
On September 25, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung […]
September 25, 2024
The current legislative authority for BsUFA, authorized in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA) will expire in September 2017. The […]
September 25, 2024
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 […]
September 25, 2024
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 […]
September 25, 2024
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 […]
September 25, 2024
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 […]
September 25, 2024
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 […]
September 25, 2024
TOPLINE: Electronic health record (EHR)–derived family history identified 29,913 patients with familial risk for hereditary breast and ovarian cancer, but 82% had no evidence of genetic […]
September 25, 2024
MADRID — High-quality data from European diabetes registries are essential for informed decision-making in clinical practice, research, policy, and regulation, experts said during a session at […]
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