15 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 | 4 days 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 | about 18 hours 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 Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 18 hours 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 - 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 18 hours ago

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

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 18 hours 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 | about 18 hours 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 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 | about 18 hours 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 Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 18 hours ago

label changes to mitigate risks of serious adverse events associated with use of OTC monograph drug products.  This research project is aligned with two critical FDA Focus Areas of Regulatory Research

FDA Dosage Optimization of Antibody-Drug Conjugates

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 18 hours ago

pharmacology, drug development, and regulatory affairs across multiple sectors. Expected Learning Outcomes: Understand the components of ADCs including antibody targets, payload mechanisms, linker chemistry, and

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 18 hours ago

clinical data from multiple sources within FDA's information systems. You will gain regulatory science experience and policy development insight that supports advancement in clinical pharmacology, drug