27 multiple-sequence-alignment positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Statistical Methods for Three-Arm Clinical Trials with Multiple Testing Procedure

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 2 months ago

generic drugs. These efforts cover more than just medicines. Research Project: In-vivo, in-vitro and therapeutical bioequivalence studies often involve comparing multiple test groups with a common control

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Antigingivitis/Antiplaque Monograph

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 20 days ago

diversity across patient populations, including pediatrics, largely due to the revolutionary acceleration of DNA sequencing technology, driven by the development of Next-Generation Sequencing (NGS) and its

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

analyses from recent submissions/literature with emphasis on clinical interpretability, multiplicity control, estimands, and alignment with common regulatory expectations. Analyze operating characteristics

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 20 days ago

*Applications will be reviewed on a rolling-basis. FDA Office and Location: Multiple opportunities are available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and

FDA Fellowship - Large language Models in Post-Market Surveillance of Drugs Using Social Media

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 20 days ago

, and drug safety. You will have a unique opportunity to be trained by experts in these fields through direct mentorship. OSE has multiple ongoing opportunities that will allow you the opportunity

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 20 days ago

collaborate with FDA scientists to compile immunogenicity assessment data from multiple regulatory sources, including Biologics License Applications (BLAs), validation reports, and clinical pharmacology review

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 20 days ago

clinical trials when bioequivalence and qualitative comparability to the reference product are demonstrated. However, differences in product quality attributes (including sequence variants and process

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 20 days ago

differences and similarities, with the goal of identifying opportunities for global alignment. Additionally, the research will assess the rationale or criteria used in each region to support issuance

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 20 days ago

information from multiple endpoints. You will collaborate with FDA scientists to address multiplicity issues due to multiple looks and multiple endpoints and analyze adaptive trial designs using Bayesian

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 7 days ago

technology, which has been identified as a rapid microbial method that aligns with current pharmaceutical industry trends, to better support submissions utilizing this approach. Researching collaboratively