You may not know that not all products undergo premarket approval — that is, a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already for sale.
,,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.
,,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.
,,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
,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
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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,,YLkL_6roBGE,, Health, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_YLkL_6roBGE,You may not know that not all products undergo premarket approval — that is, a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already for sale.
