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  1. Regulatory Science in Action

CDER Scientists in their Own Words

Video discussions of how current challenges in regulatory science are being met

Scientists and physicians from multiple disciplines conduct research to ensure to ensure that FDA and drug developers have the tools they need to ensure that drugs are safe and effective.

Kathryn Aikin, Ph.D.

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Dr. Kathryn Aikin from CDER’s Office of Prescription Drug Promotion discusses how social scientists ensure that communications about prescription drugs are truthful, balanced, and accurate.

Celia Cruz, Ph.D.

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Dr. Celia Cruz explains how CDER’s Division of Product Quality Research works to enable innovation by focusing on increasing product quality and ensuring drug products are more widely available to the American public.

Lisa LaVange, Ph.D.

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Dr. Lisa LaVange explains how CDER’s Office of Biostatistics examines evidence in pre- and post-market settings to help provide safe and effective medicines to patients.

Raj Madabushi, Ph.D.

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Dr. Raj Madabushi discusses how CDER’s Office of Clinical Pharmacology applies different approaches, including mathematical modeling of drug data, to improve the drug development process.

Karen Mahoney, M.D.

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Dr. Karen Mahoney, from CDER’s Division of Nonprescription Drug Products, discusses its work to make Naloxone, an opioid overdose reversing drug, available over-the-counter.

Michael Nguyen, M.D.

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Dr. Michael Nguyen discusses Sentinel, FDA CDER’s active surveillance program to efficiently monitor the safety of medical products on a massive scale.

Ashutosh Rao, Ph.D.

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Dr. Ashutosh Rao explains how CDER’s Office of Biotechnology Products’ research can help patients answer questions like “I left my medication on the kitchen counter for 6 hours, should I still take it?”

Amy Rosenberg, M.D.

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Find out how Dr. Amy Rosenberg and CDER’s Office of Biotechnology Products engineer therapeutic proteins for optimal effectiveness and safety.

Connie Ruzicka, Ph.D.

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Dr. Connie Ruzicka discusses portable technology developed by CDER’s Division of Pharmaceutical Analysis that can screen dietary supplements to ensure they are safe and effective.

David Strauss, M.D., Ph.D.

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Dr. David Strauss discusses projects from CDER’s Division of Applied Regulatory Science, including genetic analysis tools to predict how a patient will respond to a drug.

Daniela Verthelyi, M.D., Ph.D.

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Dr. Daniela Verthelyi has worked at FDA for almost 20 years. Find out about her research on biologics with the FDA CDER Office of Biotechnology Products.

Kimberly Witzmann, M.D.

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Dr. Kimberly Witzmann explains how CDER’s Office of Generic Drugs determines whether a generic drug is bioequivalent and pharmaceutically equivalent to its brand-name counterpart.

Lynne Yao, M.D.

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Dr. Lynne Yao discusses the need to develop safe and effective drugs for children, pregnant and lactating women, which CDER’s Office of New Drugs’ Division of Pediatric and Maternal Health works to address.

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