Quander

02:10:03

9/19 Workshop #2: Discuss Methodologic & Other Challenges Related to Patient Experience Data- Part 1

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206 views 1 year ago

01:57:19

9/18 Workshop #2: Discuss Methodologic & Other Challenges Related to Patient Experience Data- Part 2

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170 views 1 year ago

08:44:00

190th Vaccines and Related Biological Products Advisory Committee Meeting

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2K views 1 year ago

01:40:21

Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment

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753 views 1 year ago

00:36:41

REdI 2024 | D2S08 – Compliance Approaches to Emerging Threats

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276 views 1 year ago

00:42:05

REdI 2024 | D2S05 - Artificial Intelligence/Machine Learning: The New Frontier of Drug Development..

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512 views 1 year ago

,This presentation introduced background information on artificial intelligence and machine learning in pharmaceutical development and described the current landscape of AI/ML-related submissions and reviews at CDER. The session listed key challenges associated with AI/ML applications and discussed evolving regulatory considerations for these technologies. AI/ML-related activities within the Office of Clinical Pharmacology were highlighted to demonstrate the agency's comprehensive approach to integrating these emerging technologies into drug development and regulation. Timestamps 02:55 – AI/ML and Related terminology 04:48 – Important Types of Neural Networks 07:27 – Opportunities for the Application of AI/ML in Drug discovery, Drug Development and Patient Care 12:25 – Regulatory Considerations for AI/ML in Drug Development (Personal Opinion, Still Evolving) 14:37 – Review Examples 22:08 – Challenges in the Application of AI/ML 25:30 – AI/ML Activities in Office of Clinical Pharmacology (OCP)/FDA 29:30 – Questions Speaker: Qi Liu, PhD, MStat, FCP Associate Director for Innovation & Partnership Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) Center for drug Evaluation and Research (CDER) | FDA Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2024 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - https://twitter.com/FDA_Drug_Info Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367

00:17:37

REdI 2024 | D1S02 – Keynote Address

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56 views 1 year ago

00:16:41

FDA Direct — Understanding New World Screwworm w/ FDA's Vet Expert

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2K views 1 year ago

00:28:43

FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids

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2K views 1 year ago

00:01:43

FDA PreCheck Program to Boost U.S. Drug Manufacturing

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2K views 1 year ago

00:33:21

FDA Direct: Sounding the alarm on 7-OH

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6K views 1 year ago

00:04:05

HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods

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2K views 1 year ago

01:57:54

FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy

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17K views 1 year ago

02:00:21

FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women

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176K views 1 year ago

00:48:52

FDA Direct: From Menopause to Food Safety: FDA's Latest Regulatory Priorities

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14K views 1 year ago

00:01:41

FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women Invitation

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14K views 1 year ago

00:17:19

FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices

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10K views 1 year ago

00:30:24

FDA Direct: Priorities for a New FDA

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11K views 1 year ago

00:00:31

Don’t be Influenced (PSA, 30 seconds)

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1K views 1 year ago

02:55:58

FDA Roundtable on Cell and Gene Therapy

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24K views 1 year ago

01:50:11

Expert Panel with the FDA on Talc

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9K views 1 year ago

07:44:43

Generic Drugs Forum (GDF) 2025 - Day 2

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4K views 1 year ago

08:21:10

Generic Drugs Forum (GDF) 2025 - Day 1

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4K views 1 year ago

04:59:26

FDA Clinical Investigator Training Course (CITC) 2024 (Day 2 of 3)

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6K views 1 year ago

00:01:00

The Science of Generics: An FDA Researcher's Perspective | Researching FDA

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2K views 1 year ago

00:00:44

18. The FDA regulates the collection of blood and blood components. #FDAFacts

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576 views 2 years ago

00:00:22

13. The FDA encourages diverse participation in clinical trials. #FDAFacts

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234 views 2 years ago

00:00:30

How does the FDA approve new drugs? (30 seconds)

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511K views 2 years ago

00:00:13

How FDA is Using "Organ on a Chip" Technology to Improve Drug Evaluation Research | Researching FDA

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5K views 2 years ago

00:00:44

Get the Facts on Chemicals in Foods with the U.S. Food and Drug Administration

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2K views 2 years ago

00:00:24

10. The FDA is responsible for protecting the public health #FDAFacts

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774 views 2 years ago

00:00:11

5. FDA does not approve medical product companies, health care facilities, labs, or manufacturers

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2K views 2 years ago

00:00:12

⏳Loading our new #FDAFacts series on products that are (and aren’t) FDA approved.

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851 views 2 years ago

00:04:55

10 Facts about What FDA Does and Does Not Approve #FDAFacts (1-10)

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28K views 2 years ago

00:13:30

Importing FDA-Regulated Products: Human Foods

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31K views 3 years ago

,If you are importing a food product, there is a good chance it is regulated by the Food & Drug Administration (FDA). The agency regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture. The regulatory requirements may depend on the specific nature of your product. Whether you are a food importer, exporter, supplier, or customs broker, this video will provide helpful information on the FDA import process for food including: 00:00 - Introduction 01:53 - Researching The Requirements 03:04 - Food Facility Registration 03:58 - Food Safety Standards 06:43 - Labeling and Nutrition 07:36 - Prior Notice 08:13 - Additional Requirements 09:17 - Declaring the Shipment 10:59 - FDA Admissibility Decision Additional Resources: For more information please visit: o FDA’s Import Program - http://www.fda.gov/imports o Importing Human Foods - https://www.fda.gov/industry/importing-fda-regulated-products/importing-human-foods o Prior Notice - https://www.fda.gov/food/importing-food-products-united-states/prior-notice-imported-foods o Food Facility Registration - https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions o Labeling and Nutrition - https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/labeling-nutrition-guidance-documents-regulatory-information Food Safety  Human Food Preventive Controls (PCs) - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food  Current Good Manufacturing Practices (cGMPs) - https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements  Hazard Analysis Critical Control Point (HACCP) - https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/hazard-analysis-critical-control-point-haccp  Foreign Supplier Verification Program (FSVP) - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals o How to Start a Food Business - https://www.fda.gov/food/food-industry/how-start-food-business o Voluntary Qualified Importer Program (VQIP) - https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip

01:56:15

Understanding FDA Inspections and Data

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14K views 3 years ago

,FDA provides an overview of drug manufacturing inspections; a general understanding of Current Good Manufacturing Practices (CGMPs) and FDA Inspections; and demonstrates where inspection data is found on FDA’s website and share how to navigate the FDA Inspection Dashboard. Timestamps 01:35 – Applicable Manufacturing Standards 10:22 – Understanding CGMP Inspections and 483s 24:39 – FDA Regulatory Actions & How FDA Reviews Inspectional Findings 39:21 – Where to Find Inspection & Other Compliance Documents 41:45 – FDA Inspections Dashboard Demo 49:04 – Q&A Discussion Panel Speakers | Panelists: Jennifer Maguire Director, Office of Quality Surveillance (OQS) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) FDA Simone Pitts Pharmaceutical National Expert Office of Regulatory Affairs (ORA) | FDA Francis Godwin Director, Office of Manufacturing Quality (OMQ) Office of Compliance (OC) | CDER | FDA Darshini Satchi Deputy Director, Division of Information Disclosure Policy (DIDP) Office of Regulatory Programs (ORP) | CDER | FDA Rob Bughman Project Manager, FDA Inspection Dashboard ORA | FDA Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/understanding-fda-inspections-and-data-09062023 ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2022 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-UxcxbzCGn90m38cXN2DL2i3VmD SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - https://twitter.com/FDA_Drug_Info Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367