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Summary Type Topic
Biosimilars Level 1: Foundational Concepts Health Care Professional Biosimilars
Biosimilars Level 2: Regulatory and Scientific Concepts Health Care Professional Biosimilars; Drug Regulatory Process
Biosimilars Videos Healthcare Professional; Videos Biosimilars; Drug Regulatory Process
Drug Approval Case Studies Health Care Professional; Industry Drug Regulatory Process
FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond Health Care Professional; CE Eligible Drug Regulatory Process
Practitioners’ Guide for Improving Oral Anticoagulant Use Health Care Professional; CE Eligible Oral Anticoagulant; Disease States
The FDA Bad Ad Program and Prescription Drug Promotion Health Care Professional; CE Eligible Prescription Drug Promotion
FDA MedWatch and Patient Safety Health Care Professional MedWatch; Drug Safety
The FDA Process for Approving Generic Drugs Health Care Professional; Industry Drug Regulatory Process; Drug Development; Generic Drugs
FDA Overview of Biosimilar Products Health Care Professional; Industry Biosimilars
Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemia Events in Patients with Type 2 Diabetes Health Care Professional Diabetes; Disease States
Electronic Common Technical Document (eCTD) Industry Electronic Submissions
Best Practices for Communication Between FDA and IND Sponsors During Drug Development Industry Drug Development; IND
Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA) Industry Drug Development; Generic Drugs
GDUFA Self-Identification (SPL) Submission – Part 1 Industry Drug Development; Generic Drugs
GDUFA Self-Identification (SPL) Submission – Part 2 Industry Drug Development; Generic Drugs
Bringing an Over-the-Counter (OTC) Drug to Market Industry Drug Development; OTC Drug Regulations
Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND Industry Drug Development; IND
Engaging with the FDA During New Drug Development Industry Drug Development
Human Drug Establishment Registration and Drug Listing Compliance Industry Registration and Listing
Director's Corner Podcasts Industry; Podcasts Drug Regulatory Process; Drug Development
Drug Information Soundcast in Clinical Oncology (D.I.S.C.O) Health Care Professional; Industry; Podcasts Cancer Drugs
FDA Drug Safety Podcasts Health Care Professional; Industry; Podcasts Drug Safety
Regulatory Science at CDER Podcasts Industry; Podcasts Drug Development
Small Business and Industry Assistance (SBIA) Chronicles Industry; Podcasts Drug Regulatory Process; Drug Development
FDA's Biomarker Qualification Program Industry; Videos Biomarker; Drug Development
Biosimillars Patient and Prescriber Outreach Materials Health Care Professional; Videos Biosimilars; Drug Regulatory Process; Drug Development
FDA Drug Info Rounds Health Care Professional; Videos Drug Safety; MedWatch; IND; Drug Development; Drug Regulatory Process; Prescription Drug Promotion; Disease States; Registration and Listing; Generic Drugs
GDUFA II Videos and Resources Industry; Videos Drug Development; Generic Drugs
Regulatory Science at CDER Videos Industry; Videos Drug Regulatory Process; Drug Development
Biosimlars Online Courses, Webinars, and Presentations Health Care Professional; Industry; Webinars Biosimliars; Drug Regulatory Process; Drug Development
CDER Small Business and Industry Assistance (SBIA) Learn Health Care Professional; Industry; Webinars Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Registration and Listing; Electronic Submissions; Biosimilars; Drug Safety; IND
CDER Webinars Health Care Professional; Industry; Webinars Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Registration and Listing; Electronic Submissions; Biosimilars; Drug Safety; MedWatch; IND; Disease States; Prescription Drug Promotion; Cancer Drugs
Division of Drug Information Webinars Health Care Professional; Webinars; CE Eligible Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Biosimilars; Drug Safety; MedWatch; IND; Disease States; Prescription Drug Promotion; Cancer Drugs
Compounding Quality Center of Excellence On-Demand Training Health Care Professional; Industry; Webinars; CE Eligible Compounding; Drug Regulatory Process; Generic Drugs

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