What Does FDA Regulate?

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Do you know how many of the products you use every day are regulated by the #FDA? About 20 cents of every dollar you spend is on a product regulated by the FDA. But do you know what to contact FDA about since our agency’s responsibilities are closely related to those of several other government agencies?

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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

,,TM56dzCfq-Q,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_TM56dzCfq-Q,On September 18th and 19th 2025, FDA hosted a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders. This workshop featured presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present. In addition, this workshop presented a draft version of an updated evidence dossier template to facilitate the submissions of evidence to FDA to support a Clinical Outcome Assessment.

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

,,DwXNIDqpdOM,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_DwXNIDqpdOM,On September 18th and 19th 2025, FDA hosted a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders. This workshop featured presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present. In addition, this workshop presented a draft version of an updated evidence dossier template to facilitate the submissions of evidence to FDA to support a Clinical Outcome Assessment.

08:44:00

190th Vaccines and Related Biological Products Advisory Committee Meeting

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2K views 1 year ago

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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

,,wns7dVIW4V4,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_wns7dVIW4V4,On September 24, 2025, the Food and Drug Administration (FDA) held a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment," to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Amendments (BsUFA III). This assessment built upon the findings from three previous assessments conducted by independent contractors under previous PDUFA and BsUFA reauthorizations. For more background information on the meeting, please see the Federal Register Notice with assigned docket FDA-2025-N-2962. https://www.federalregister.gov/documents/2025/08/25/2025-16245/prescription-drug-user-fee-act-and-biosimilar-user-fee-amendments-hiring-and-retention-assessment To provide a public comment, please visit the public docket. The public docket closes on October 24, 2025. https://www.regulations.gov/document/FDA-2025-N-2962-0001

00:36:41

REdI 2024 | D2S08 – Compliance Approaches to Emerging Threats

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276 views 1 year ago

,FDA,CDER,SBIA,Regulatory,Education,Industry,REdI,Clinical,Trial,Compliance Approaches,Emerging Threats,Pharmaceutical Inspection,Compliance Data,Bioresearch Monitoring,BIMO,Drug Supply Chain,Recalls,Compounded Drugs,Drug Registration and Listing,Oversight,Compliance,Warning Letters,Closing,QWIX857Shsk,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_QWIX857Shsk,The closing remarks to wrap up the Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development. Timestamps 01:08 – Oversight Responsibilities 02:18 - Mission 02:33 – Compliance Tools and Activities 05:53 – Risk-Based Compliance Actions 06:39 – Safeguarding the Drug Supply Chain 12:09 – Remote Tools 17:24 – Ophthalmic Products 22:08 – Unapproved Drugs 24:45 – Warning Letters Issued 26:08 – Outreach and Communication 28:09 – Pharmaceutical Inspections and Compliance 31:12 – FDA Data Dashboard 33:34 – Unified Compliance 35:50 – Summary Speaker: Jill P. Furman, JD Director Office of Compliance (OC) 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

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