Drugs

Videos and Podcasts on Regulatory Science at CDER

Learn how CDER is advancing regulatory science to protect public health.

Dr. Janet Woodcock – Advancing Regulatory Science for Public Health

 

Patient-Focused
Drug Development

Patient-Focused Drug Development

Podcast Transcript
FDA meets with patients to get their perspective of the impact of their condition on their daily life and on their treatment. See how patients play a role in determining how drugs are developed.

 

Importance of
Partnerships

The Importance of Partnerships and Consortia

Podcast Transcript
FDA works with partners and consortia to help identify scientific gaps in drug development. Find out how these relationship improve FDA’s ability to review drugs.

 

Real World Evidence

Real World Evidence

Podcast Transcript
Real-world evidence is information on patient’s health and health care that comes from multiple sources within and outside the clinical setting. Learn how FDA is using it.

 

Improving
Drug Review with Data Standards
Improving Drug Review with Data Standards

Podcast Transcript
Data standards make the exchange of data predictable and consistent and ensure data is in a form that scientific tools can use. Learn how data standards are improving drug review at CDER.

 

CDER Researchers – In Their Own Words

Kathryn AikIn, Ph.D.

Kathryn Aikin, Ph.D.

Podcast Transcript
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

Celia Cruz, Ph.D.

Podcast Transcript
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

Lisa LaVange, Ph.D.

Podcast Transcript
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

Raj Madabushi, Ph.D.

Podcast Transcript
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.

Karen Mahoney, M.D.

Podcast Transcript
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 Ngyuen

Michael Nguyen, M.D.

Podcast Transcript
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.

Ashutosh Rao, Ph.D.

Podcast Transcript
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.

Amy Rosenberg, M.D.

Podcast Transcript
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.

Connie Ruzicka, Ph.D.

Podcast Transcript
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

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

Podcast Transcript
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.

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

Podcast Transcript
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

Kimberly Witzmann, M.D.

Podcast Transcript
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.

Lynne Yao, M.D.,

Podcast Transcript
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.

 

Page Last Updated: 11/16/2017
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