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…
Search for Regulatory References | Drugs
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
Drug Quality Sampling and Testing Programs
FDA CDER’s quality sampling and testing programs assess pharmaceutical quality after drugs are on the market.
FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult…
FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has…
Chengdu Innovation Pharmaceutical Co., Ltd. – 698786 – 02/05/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated