Hormone Replacement Therapy (HRT) for women offers an important option for alleviating the symptoms of menopause and recognizing other health benefits. However, for years use of this option has been discouraged due to a large amount of confusion and anxiety on the topic. We're convening an expert panel at the FDA on July 17, 1-3 p.m. ET to discuss the latest evidence on HRT and set the record straight.
,,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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,The Late Show,Late Show,Stephen Colbert,Steven Colbert,Colbert,celebrity,celeb,celebrities,late night,talk show,comedian,comedy,CBS,joke,jokes,funny,funny video,funny videos,humor,hollywood,famous,0ZW-icIM01U,, Politics,Society,Television_program, channel_UCMtFAi84ehTSYSE9XoHefig, video_0ZW-icIM01U,Dr. Anthony Fauci tells Stephen about his recent testimony before Congress and what he perceives as the dangerous politicization of science in American life. Stick around for more with Dr. Fauci and look for his new memoir, 'On Call,' available now.
#Colbert #OnCall #DrFauci #AnthonyFauci #Books
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Stephen Colbert brings his signature satire and comedy to THE LATE SHOW with STEPHEN COLBERT, the #1 show in late night, where he talks with an eclectic mix of guests about what is new and relevant in the worlds of politics, entertainment, business, music, technology and more. Featuring bandleader Louis Cato and ���THE LATE SHOW band,��� the Peabody Award-winning and Emmy Award-nominated show is broadcast from the historic Ed Sullivan Theater. Stephen Colbert took over as host, executive producer and writer of THE LATE SHOW on Sept. 8, 2015.
,Paul ingrassia texts,paul ingrassia lawyer,paul ingrassia politico,trump nominee,nazi streak,paul ingrassia withdraws,Trump,Republicans,politics,US news,philip defranco,pds,news,9LqWEBQKKzM,, Politics,Society, channel_UCpLB7kBu9O5dbBKhaIOmqcQ, video_9LqWEBQKKzM,Watch The Full Philip DeFranco Show: https://www.youtube.com/defranco?sub_confirmation=1
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Trump’s Guy Paul Ingrassia is out. right, he's now officially withdrawn his nomination to lead the office of special counsel after he told Republicans over text that he had a “n*zi streak,” among other things. right, like as we talked about yesterday, that was just one of the controversial and racist text messages that he sent other Republicans in a group chat that was leaked to Politico by one of the people in the chat. though again, as we talked about, you had his lawyer both trying to frame his comments as a joke while also suggesting that they might be fake. but seemingly, you had a lot of people just not believing that, including multiple key Republican senators who announced that they would vote against Ingrassia’s confirmation. right, with some even suggesting that the white House should pull his nomination in the wake of the leak. though that is of course not necessary, since you Ingrassia announcing on x that he was withdrawing ahead of a now canceled Senate hearing on his nomination that have been set for tomorrow. writing: “Unfortunately, I do not have enough Republican votes at this time.” And adding, “I appreciate the overwhelming support that I have received throughout the process and will continue to serve president Trump and this administration to make America great again!” and that last part is important here because you have many wondering how exactly Ingrassia will continue to serve now that his nomination has been pulled. right, because if you didn't know, while going through the confirmation process to lead the Office of Special Counsel, Ingrassia has been working as a white House liaison with the Department of Homeland Security. and at least as of recording, we've seen numerous reports saying that Ingrassia still has his liaison job. and so far, the white House has refused to respond to questions from multiple outlets about whether he'll be staying on in that role. with the question seeming to be if his, n*zi streak problem is just too much for the Senate. But that doesn't mean it's too much to work in the Trump administration.
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Produced by: Cory Ray, Philip DeFranco
Edited by: James Girardier, Maxwell Enright, Julie Goldberg, Christian Meeks, Matthew Henry
Art Department: William Crespo
Writing/Research: Lili Stenn, Philip DeFranco
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#Trump #Politics #PaulIngrassia
,1,HAPPY NEW YEAR! Make no mistake this is the last time to say that because every year after is going to be Happy Chinese New Year because of Emporer Biden. WEI ZHONG XIAN! Just joking! It's a great time in the studio, boys are back looking back at the year and talking Nazis and NASA. WILD! This has been the worst year, because of COVID-19, or has it been because Trump won? It doesn't matter, overall we can all agree that it was a shit year.
Chris and Yanni get some dope gifts from Homelesspimp AKA Binky AKA Loaf AKA Mike Lavin our amazing producer. Go check this out on video because it's hilarious to see Chris's "Make AOC Bartend Again" and Yanni finally become his doppelganger, the kid looks jacked!
The Cuzzies break down the history of Operation Paperclip. THE US GOVERNMENT IS ON NOTICE! Did you know that NASA hired ex-Nazi scientist from Germany? The German scientists were bad guys but we needed to keep Russia away from us, so we hired the bad guys to help us get to the moon first. Did you know the Cold War was that bad?
We told them, listen forget about your old life, tell everyone you wanted to come here to see Micky Mouse and build some rockets. At this Time Harry Truman was in office (he was the original Kamala Harris because he served as vice president first!) and he denied these facts, but was the one who signed off on it.
So yeah, Nazis got the USA to the moon, 2020 was a squeak of a year BUT a WILD WILD year for the History Hyenas. Tell us your favorite clip from this year bubbas!
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REMINDER BABES: Even though Trump did not follow through with his promise to build a wall, Chris and Yannis did. It’s a Bay Ridge Boys wall and you can find it at patreon.com/bayridgeboys. CHECK IT OUT CUZ
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This is brought to you by Tim Dillon's Belly Hair in support of the Gary Sinise Foundation. If you don't know who Gary Sinise is, you need to break out the VHS and watch Forest Gump as Tom Hanks plays a total Frank and Beans who befriends Sinise's character, LT. Dan. He has been raising money and advocating for veterans for more than 15 years. Your donations will go to good use: https://www.garysinisefoundation.org/
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,9news,australianews,brisbanenews,channel9,channel9news,latestnews,melbournenews,newsaustralia,ninenews,ninenewsaustralia,sydneynews,Victoria crime crisis,Melbourne tourism down,Victoria tourism crisis,crime driving away visitors,Victorian opposition statement,Melbourne crime news,tourism industry impact,breaking news Victoria,Victoria safety concerns,crime effect on tourism,Victorian politics,local news Melbourne,tourism decline,crime statistics,hRK8xLg39v0,, Politics,Society,Television_program,Tourism, channel_UCIYLOcEUX6TbBo7HQVF2PKA, video_hRK8xLg39v0,Victoria's opposition says the state's crime crisis is driving down tourism and keeping away visitors. | *Subscribe and ?: http://9Soci.al/KM6e50GjSK9*
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,Yahoo Finance,Personal Finance,Money,Investing,Business,Savings,Investment,Stocks,Bonds,FX,Currencies,NYSE,Equities,News,Politics,Market,Markets,Yahoo FInance Premium,Stock market,mJ-b_f5sFsQ,, Business,Society, channel_UCEAZeUIeJs0IjQiqTCdVSIg, video_mJ-b_f5sFsQ,With Thanksgiving week kicking off, Yahoo Finance's Markets Reporter Jared Blikre analyzes historical trends that emerge during this holiday trading period. Blikre breaks down typical equity market performances over Thanksgiving week, examining the historical data points in key indexes like the S&P 500 (^GSPC), Nasdaq Composite (^IXIC), and Russell 2000 (^RUT).
For more expert insight and the latest market action, click here to watch this full episode of Yahoo Finance Live.
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,1,This week's top stories of the week include:
0:15 These 'robo-boots' may improve balance - They provide a super-quick blast of assistance to your muscles helping you to stay upright. Scientists asked a healthy participant to stand on a moving floor wearing the exo-boots. Then ‘pulled the rug’ out from under them. They programmed the boots to work using the same delay as human reflexes or artificially faster than humanly possible. The exo-boots only improved balance when they worked faster than our natural response. It means that, one day, wearable exoskeletons could deploy lightning-quick reflexes to help people with balance impairment.
1:35 This new telescope could help explain dark energy - A new space telescope is being launched by the European Space Agency to help scientists build a 3D map of the universe by photographing billions of galaxies up to 10 billion light years away – across more than a third of the sky. Around 95% of the universe is ‘dark matter’ or ‘dark energy’ which doesn’t fit into our cosmological models. The super-sensitive telescope will effectively enable us to look back in time to how distant galaxies looked 10 billion years ago and to see how dark energy accelerated the expansion of the universe.
3:10 How to build earthquake proof buildings - When an earthquake strikes, it creates horizontal forces that shake the building from left to right. Concrete is very strong when compressed, but it has little flexibility, and when stretched, as it is during an earthquake, it's liable to crack. So to create earthquake resistant buildings, designers add a flexible steel skeleton known as rebar.
The steel is elastic and springs the building back into shape. Sometimes, when tension is too high, the steel may warp permanently. This is advantageous, though, because it keeps the building upright, enabling people to escape. There are other ways to make earthquake resistant buildings. Watch the video to learn more.
4:34 Climate doom is a dangerous myth - It’s the most common false claim about climate change, especially among young people. Some experts believe it’s more damaging than climate denialism. In fact, scientists say, it’s not too late to arrest global warming. Global temperatures will stabilize a few years after we reach net zero and the belief that it’s pointless trying to stop climate change only leads to inaction. Making it as unhelpful as denying climate change altogether.
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,,sUUygn4nzZk,, Health,Society, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_sUUygn4nzZk,Hormone Replacement Therapy (HRT) for women offers an important option for alleviating the symptoms of menopause and recognizing other health benefits. However, for years use of this option has been discouraged due to a large amount of confusion and anxiety on the topic. We're convening an expert panel at the FDA on July 17, 1-3 p.m. ET to discuss the latest evidence on HRT and set the record straight.
