,,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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,1,Morocco is reeling after a powerful 6.8 magnitude earthquake hit the centre of the country killing at least 1,037 people and injuring more than 1,200 others.
(Subscribe: https://bit.ly/C4_News_Subscribe)
The epicentre was in the remote Atlas mountains with most of the dead feared to be in remote, hard to access areas.
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,1,Police had been searching for 47-year-old Jason Pass for three days. They finally caught up to him on Wednesday in Bath Beach. CBS New York's John Dias reports.
,movies,gaming,entertainment,hollywood,streaming,netflix,hbo,DngqdAnZmSU,, Lifestyle_(sociology),Physical_fitness, channel_UCfwE_ODI1YTbdjkzuSi1Nag, video_DngqdAnZmSU,Forget Planet Fitness, Check Out Coffee Brand Coffee! Join Jeremy's Club to save HUGE https://coffeebrandcoffee.com/
,1,After tense negotiations, nations agreed to establish a loss and damage fund to help poorer countries that have contributed least to climate change cope with the devastating impacts. The World Bank will initially manage the fund and the European Union has said it will make a "substantial" financial contribution. Irish Minister of Environment Eamon Ryan, a lead negotiator for the EU on the fund, discusses how polluters should be paying more, the switch away from fossil fuel subsidies, and how renewables are the "peace project of our time." And finally, what we should expect from leaders at this year's COP28 Climate Conference.
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,1,From distant gunshots to daring escapes by students and teachers, Uvalde residents were some of the first to start filming outside Robb Elementary School on May 24, shortly after a gunman went inside and fatally shot 19 children and two adults. (June 1)
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,1,PBD Podcast Episode 266. In this episode, Patrick Bet-David is joined by Tim Pool and Adam Sosnick.
FaceTime or Ask Patrick any questions on https://minnect.com/
0:00 - Start
3:18 - Tim Pool On Why He Hates Corporate Media
6:58 - Tim Pool On Schools
16:42 - Tim Pool Breaks Down His Fall Out With VICE
37:35 - Vice Media $400 Million Bailout!?
47:15 - Did Biden Manipulate The Employment Rate?
54:41 - Tim Pool On Why Vivek Ramaswamy Will Be a Great President
1:01:24 - Tim Pool On Why Trump Should Not Debate DeSantis
1:04:48 - Tim Pool On Chris Hayes's Attack On Trump
1.12:47 - Should We Ban Gender-Affirming Care For Youths?
1:28:23 - Tim Pool SLAMS Peter Thiel's Views On DeSantis
1:35.03 - Why Leftist Media Will Never Be Held Accountable
1:41:08 - Tim Pool On Why Trump Will Be a Great President
1:49:50 - Tim Pool Explains How Trump Would End The Ukrainian War In One Day
1:56:42 - Was U.S Behind Kremlin Drone Attack?
2:08:19 - Tim Pool's Wildcards For The 2024 Election
2:17:18 - Kanye West Fires Nick Fuentes From Political Team And Rehires Milo Yiannopoulos
2:26:12 - Tim Pool Roasts Sam Seder
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Patrick Bet-David is the founder and CEO of Valuetainment Media. He is the author of the #1 Wall Street Journal bestseller Your Next Five Moves (Simon & Schuster) and a father of 2 boys and 2 girls. He currently resides in Ft. Lauderdale, Florida.
,Andrew Bustamante Interview,Andrew Bustamante,Andrew Bustamante cia,cia interview,deep state,what is deep state,intelligence agencies,trump cia,trump fbi,biden cia,biden fbi,2024 election,trump 2024,biden 2024,trump,biden,trump vs biden,donald trump,joe biden,robert f kennedy kr,rfk jr,economy,immigration,inflation,abortion,crime,democracy,biden presidency,OJz5P4K8sGQ,, Politics,Society, channel_UCvixJtaXuNdMPUGdOPcY8Ag, video_OJz5P4K8sGQ,-- Andrew Bustamante, former covert CIA officer and founder of the Everyday Espionage training platform, joins David to discuss his work, political bias within intelligence agencies, and much more. Check out Andrew's platform: https://yt.everydayspy.com/Pakman
Find you secret spy superpower: https://yt.everydayspy.com/Pakman
Follow Andrew on YouTube: https://www.youtube.com/@Andrew-Bustamante
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,1,'Black History Month' honors the achievements and contributions of African Americans throughout U.S. history. Originating from “Negro History Week” in the vision of Carter G. Woodson and other prominent African Americans, it became an official month-long celebration in 1976, recognized by President Gerald Ford.
The 2024 theme, “African Americans and the Arts,” highlights the profound impact African Americans have had on visual arts, music, cultural movements, and beyond.
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This untitled instructional film presented by the US Army from the 1950s shows an American soldier setting up various models of American-made military-grade landmines used throughout the Cold War. A land mine is an explosive device concealed under or on the ground and designed to destroy or disable enemy targets. The use of land mines is controversial because of their potential and indiscriminate weapons. They can remain dangerous many years after a conflict has ended and pose a threat to civilian safety. During the Cold War the United States used the M6 anti tank mine and trip-wire operated bounding antipersonnel mines such as the M2 and M16 which are some of the explosives featured in this instructional film.
Close-up of landmine being buried in soil (0:09). Hand turns dial on top of the landmine (0:40). A US Army soldier sets up and charges a 1950s M6 Landmine (0:51). Soldier sets up M14 Blast Mine (1:20). Soldier buries and disguises the M14 (3:45). Soldier places a safety pin around the indicator arrow to prevent premature explosion (4:16). Illustration of how buried M14 Landmine functions (5:18). Soldier sets up M16 Landmine (5:49). Illustration of explosion radius of the M16 (7:55).
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,Joe Rogan Experience,JRE,Joe,Rogan,podcast,MMA,comedy,stand,up,funny,Freak,Party,XLi_Vr8hm9s,, Entertainment, channel_UCzQUP1qoWDoEbmsQxvdjxgQ, video_XLi_Vr8hm9s,Joey Diaz is a standup comic, actor, and author. He's the host of "The Church of What's Happening Now," and the author of "Tremendous: The Life of a Comedy Savage."
@JoeyDiaz
https://www.joeydiaz.net
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,1,Ohio voters have chosen to legalize recreational cannabis, making the state the 24th to decriminalize the possession of certain amounts by passing Issue 2 in Tuesday's election. The state also voted to protect access to abortion services with an amendment to the state constitution by passing Issue 1.
What do YOU think?
More here: https://scrippsnews.com/
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,1,Support Pakman Live:
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,DRJ Records Classics,rashmika mandanna latest south movie 2024,rashmika mandanna hindi dubbed movie,rashmika mandanna new south movie,latest blockbuster movie,hindi dubbed blockbuster movie,rashmika mandanna movie,rashmika mandanna full movie hindi dubbed,new blockbuster movie,superhit south action movie,new south action movie,hindi dubbed blockbuster movie 2024,new south movie 2024,rashmika mandanna blockbuster south indian movie,YRPp7X8E-PI,, Entertainment,Film, channel_UC8KmNGdhr6S9CiJY29cx3Vw, video_YRPp7X8E-PI,Subscribe: http://bit.ly/DRJRecordsPlay
Latest Release Hindi Dubbed Action Full Movie | Rashmika Mandanna Superhit Blockbuster South Movie
Movie : Anjani Putra
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Cinematography : Swamy J
Editor : Deepu S Kumar
Producer : M.N. Kumar
Label: DRJ Records
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,1,Over the span of his 40 plus-year career, Dr. David Cook’s focus has been on testing, monitoring, and fine-tuning vision therapy as a clinician, author and educator. As one of the nation’s leading authorities on vision therapy, Dr. Cook has given lectures on expanding depth perception to optometrists and other eye professionals at clinical seminars, study groups and optometric congresses all over the world. His book “The Shape of the Sky” teaches us that vision is something we do, and more importantly, something we can learn to do better."
EPISODE LINKS
Shape of the Sky - https://oepf.org/product/shape-sky
https://CookVisionTherapy.com
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DANNY
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OUTLINE
0:00 - Introduction
4:02 - What is Vision?
5:05 - Neuroplasticity
7:50 - Using vision to improve Intelligence
13:44 - Dyslexia
22:51 - Technology is making the world ‘near-sighted’
37:47 - Binocular vision
46:17 - 3D vision in super athletes
1:03:14 - Vision & personality
1:12:56 - Knowledge by experience VS acquaintance
1:20:08 - Eye games
1:33:05 - Protocols to improve reading skills
1:41:50 - How language changes perception
1:48:07 - Picasso & Rembrandt were stereo blind
1:55:59 - Color blindness
2:00:45 - Daily protocols to enhance small vision (Deep Winks)
2:05:16 - Daily protocols to enhance big vision (3D)
2:16:06 - The shape of the sky
2:20:39 - How seeing changes thinking
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