“Expert Panels with the FDA” are a series of roundtable discussions to provide an open public discourse on the latest medical and scientific information on several important topics. At this roundtable, experts will be asked to discuss health concerns related to the use of talc products.
,,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.
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
,1,Jeremy Rys is an independent science & technology researcher with a long history of research & investigation into advanced propulsion concepts. He has covered a variety of topics both directly and indirectly related to advanced propulsion, ranging from replication attempts of various devices to speculation about UAP & UFO propulsion systems.
EPISODE LINKS
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https://alienscientist.com
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EPISODE REFRENCES
• https://medium.com/@signalsintelligence
• https://www.otherhand.org/home-page/area-51-and-other-strange-places/bluefire-main/bluefire/the-bob-lazar-corner/the-lazar-timeline
• https://www.scientificamerican.com/article/the-synthetic-elements-iv
• https://www.scientificamerican.com/article/creating-superheavy-elements
• https://youtu.be/6ZVtTLkftmg
• https://www.thedrive.com/the-war-zone/30499/the-truth-is-the-military-has-been-researching-anti-gravity-for-nearly-70-years
• https://www.thedrive.com/the-war-zone/33859/blasting-the-air-in-front-of-hypersonic-vehicles-with-lasers-could-unlock-unprecedented-speeds
• https://www.thedrive.com/the-war-zone/28640/could-some-of-the-ufos-navy-pilots-are-encountering-be-airborne-radar-reflectors
• https://www.militarytimes.com/news/your-military/2019/07/19/pentagon-scientists-are-making-talking-plasma-laser-balls-for-use-as-non-lethal-weapons
• https://en.m.wikipedia.org/wiki/Electronic_counter-countermeasure
• https://en.m.wikipedia.org/wiki/Digital_radio_frequency_memory
OUTLINE
0:00 - The case against Bob Lazar
2:59 - Element 115
8:39 - Bob Lazar’s educational background
16:49 - Site 4 (S4)
21:05 - Evidence Bob made money from his story
28:30 - Mike Thigpin
34:24 - Demon core: the strange death of Louis Slotin
38:58 - Biometric bone density scanner
44:56 - Alfred Loedding flying saucer designs
50:01 - Papoose Lake
52:27 - MIT / Resume
1:04:31 - Quantam Electro Dynamics
1:13:47 - Recent UFO disclosures
1:15:07 - Roswell
1:27:00 - Light propulsion
1:42:10 - Super cavitation
1:46:12 - Tic tac UFO & ‘Cube Inside a Sphere’
1:56:40 - Mirage effect technology
2:11:19 - Biologically engineered beings
2:22:40 - Drones & cold fusion
2:41:25 - Cattle mutilation & Robert Bigelow
2:48:36 - Camp Hero / Montauk
2:56:12 - Will Bob Lazar debate Eric Weinstein?
3:03:34 - Malcolm Bendall & building the pyramids
3:23:07 - What if Bob Lazar is telling the truth?
3:31:47 - Hal Puthoff
KONCRETE
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,,MS-T1KicGOc,, Health,Society, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_MS-T1KicGOc,“Expert Panels with the FDA” are a series of roundtable discussions to provide an open public discourse on the latest medical and scientific information on several important topics. At this roundtable, experts will be asked to discuss health concerns related to the use of talc products.
