Tetracycline – Oral products
Tetracycline – Oral products
Increasing Options in Clinical Research to Facilitate Medical Product Development
FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people…
Realizing the Promise of Real-World Evidence
Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to…
FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in…
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
Evaluation of Bladder Wash as an Alternative Specimen for Postmortem Toxicology: Comparison to Screening Results of Urine and Kidney Tissue
Urine specimens represent the gold standard for screening analyses in forensic toxicology but are not always available postmortem. The current…
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
Study of Sex Differences in the Clinical Evaluation of Medical Products
This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific…
Questions and Answers on Current Good Manufacturing Practices for Drugs
As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be…
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