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 […]
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 […]
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 […]
If you’re like most primary care clinicians, your email inbox is flooded with messages from patients with questions about lab results. A common query: Should I […]
The turf war between two types of anesthesia providers is escalating: The American Society of Anesthesiologists (ASA) has filed a trademark complaint against the recently renamed […]
TOPLINE: Treatment-resistant major depression (TRD) is associated with a 17% higher risk for all-cause mortality than non-TRD major depressive disorder (MDD), a new study shows. The […]
TOPLINE: Menopausal hormone therapy (MHT) is associated with a 16% lower risk for psychosis relapse in women with schizophrenia or schizoaffective disorder (SSD), especially in women […]
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