This episode covers three critical public health topics: an upcoming expert panel on hormone replacement therapy for women and menopause, FDA's efforts to remove petroleum-based food dyes from products to protect children's health, and key insights from a collaborative discussion with the National Academy of Medicine on advancing evidence-based regulatory science.
FDA Direct,Menopause,Food Safety,Dr. Makary,Episode 12,T-ruM8GCNq0,, Health,Society, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_T-ruM8GCNq0
,,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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,NDTV 24x7,breaking news,current affairs,latest news,live news,ndtv,ndtv live 24x7 english news,top news,TV Short Clip,category= news,Reporter= J Sam Daniel Stalin,Tamil Nadu Governor,Chief Justice Of India,DY Chandrachud,MK Stalin,3npqXwQ-UPY,, Society,Television_program, channel_UCZFMm1mMw0F81Z37aaEzTUA, video_3npqXwQ-UPY,About NDTV (English news channel):
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,1,Hello our friends! We are Healers, Teachers, & Guides here to help humanity through the Great Change of The Yugas.
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,1,A large fire broke out in a building in Liverpool city centre.
Firefighters called to Fox Street shortly before 2.20pm on Saturday arrived to find a four-storey building 'well alight'.
The structure was showing signs of collapse and fire crews were evacuating nearby buildings, Merseyside fire and rescue service said
Building ‘showing signs of collapse’ after huge fire in Liverpool
,FDA Direct,Menopause,Food Safety,Dr. Makary,Episode 12,T-ruM8GCNq0,, Health,Society, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_T-ruM8GCNq0,This episode covers three critical public health topics: an upcoming expert panel on hormone replacement therapy for women and menopause, FDA's efforts to remove petroleum-based food dyes from products to protect children's health, and key insights from a collaborative discussion with the National Academy of Medicine on advancing evidence-based regulatory science.
Liam O'Malley was kicked out of his college in England for tweets supporting one of the Conservative Party's immigration policies. Likewise, American universities are beginning to reject students of the 'wrong' political persuasion.
,donald trump,trump,trump news,politics,usa,donald trump news,white house,president,republicans,democrats,donald trump rally,donald trump live,trump rally,immigrants,illegal immigrants,elon musk,war,russia,ukraine,russia vs ukraine,ukraine vs russia,russia war,ukraine war,usa vs iran,world war III,going to war,war prep,tariffs,tariff,trump tariffs,china,executive orders,big beautiful bill,ice,ice raids,deporting,gavin newsom,iran vs israel,israel,iran,tNxY9hzH8C0,, Politics,Society, channel_UCc3fZiNmyM-YRgA7W97TTVw, video_tNxY9hzH8C0,Donald Trump News, Trump sends B2 Bomber Jet to destroy Iran's nuclear sites and now they plan to retaliate. Israel and Iran trade war missiles as people are killed and wounded. Trump announces final warning to Iran and tells them to evacuate immediately. Ayatollah say's Iran won't surrender. Protestors have turned to violence and have been assaulting officers using a variety of materials resulting in attacks and arrest. ICE is raiding job sites and even arresting immigrants during scheduled meetings. Tariffs and Big Beautiful Bill: Donald Trump announces The Big Beautiful Bill which consist of massive tax breaks and security upgrades. Trump reaches new deal with China and the USA is back on top. Brandon Mason explains the new deal with China, UK, Canada and other nations. Trumps Tariffs will help adjust agreements to push for a change in the global economy. Trump says that he will lower the Tariffs as China makes a deal with the US for a better trade agreement. Is America preparing for War in this country (WWIII) as inflation rises and tension builds in the world amongst Russia, Ukraine, China, Iran, Israel, Hamas, etc. Canada and other close nations have showed frustration as Donald Trump is preparing the US for the rebuilding of our military and a nation where companies establish and build inside the country to eliminate importing goods elsewhere. Trump has placed tariffs on other countries to force proper trading and protection for the US which can also raise expenses for the near future until deals are made. Trump has also fired back at Mexico by renaming the Gulf of America. Donald Trump and Elon Musk team up to crack down on Democrats and the world is divided with trusting Elon Musk. They use DOGE which is the Department of Government Efficiency as their power source and expose and provide the truth to the American people. Trump wants to lower taxes and help businesses start back up in the United States. Some people are complaining about Musk having too much power in the White House and others are excited about his journey. Trump News starts now! #donaldtrump #trump #china #politics #usa #military.
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