14 security-"https:"-"https:"-"https:"-"https:" uni jobs at Center for Drug Evaluation and Research (CDER)
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago
ability to protect public health by supporting evidence-based approaches to ensure safety through improved labeling and/or packaging recommendations that reduces consumer misuse and prevents infections
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago
focusing on injection, otic, and ophthalmic drug products. You will gain experience evaluating the safety and manufacturing considerations of generic drug products approved in multiple jurisdictions and
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 19 hours ago
the Pediatric Research Equity Act, exceedingly few drug development programs include neonates. As a result, a relatively small number of drugs have the safety and efficacy data necessary to support
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 19 hours ago
oncology and inflammatory & immune diseases, and to support risk and safety evaluation, to identify endpoints for Type 1 Diabetes. During the appointment, you will use the clinical trial data under NDA and
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 19 hours ago
trispecific fusion proteins. Using breast and ovarian cancer cell models, you will help develop bioassays to evaluate and improve the quality, safety, and anti-tumor activity of FDA-regulated products. Learning
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago
safety evaluators to discuss findings and their implications for regulatory policy development and review practices. Presenting research findings to the Division of Clinical Pharmacology and other
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago
in these populations, to further evaluate the clinical experience during pregnancy and lactation, and to contribute to safety recommendations for drug product labeling. The models could also be used
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 19 hours ago
/product-related impurities) may alter immunogenicity risk and affect safety, pharmacokinetics, pharmacodynamics, and efficacy. Current FDA guidance (e.g., the 2021 guidance for certain highly purified
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 19 hours ago
extrapolating safety and efficacy data from adults to pediatrics. Mentor: The mentor for this opportunity is Suryatheja Ananthula (suryatheja.ananthula@fda.hhs.gov ). If you have questions about the nature
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 19 hours ago
are made for nucleotide-based therapeutics—such as antisense oligonucleotides, siRNA, and mRNA—intended for neurological diseases. The you will help investigate how safety margins, nonclinical data