#FDAFacts
The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices.
Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently.
Read more by searching "Is it really FDA Approved" on fda.gov
https://www.fda.gov/consumers/consumer-updates/10-facts-about-what-fda-does-and-does-not-approve
#FDAFacts #datosdelafda
medical facilities,fda hospitals,fda approve,doctors office,labs,drug manufacturers,Nij9rIory9w,, Business,Health, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_Nij9rIory9w
,,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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Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
,1,Genucel Skincare Most Popular Package – Introductory Special https://www.genucel.com/brand - U.S. & Canada Orders Only Use promo code Brand to get an extra 10% off your entire order.
Last week Michael Shellenberger and Matt Taibbi revealed that Chinese scientists working on gain-of-function experiments with coronaviruses at the Wuhan Institute of Virology were the first humans to contract COVID-19. A new government report has revealed that the US tax payer funded this. So, in a way, it’s your fault that the last few years happened. Thanks a lot, us. #wuhan #covid #pandemic
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My stand up special is premiering on 25th June! You will love it! Go to https://moment.co/russellbrand
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,1,#earthquake South Carolina the state below North Carolina it's a separate state has been having record earthquakes this year and last year they had way more earthquakes than normal in the past 30 days they have had over 15 earthquakes and it's just crazy do not move the South Carolina it is dangerous and you might could die because they are not really built for earthquakes I would not move to Charleston South Carolina it's a fun place to visit but trust me the bugs and the air conditioning you don't want to stay inside all the time with air conditioning you want to be outside but do not move there I live there for 8 years as an outsider and I saw more and more people moving there and just ruining the town life is not a game don't just go through life not knowing what the hell you're going to do you're probably boring somewhere and you think that town sucks no it doesn't it's you that suck so do not bring your bad attitude to some beautiful place trying to have some kind of spiritual Awakening we don't need none of that you need to get your act together and grow up you're grown up now so stop playing anyways South Carolina is having a lot of earthquakes and it's really crazy
,ice,broadview,chicago,chicago news,news,immigration,ice agents,Mnvw0GYxI5U,, Politics,Society, channel_UC_vFLohxs5PkAxlk7Y6jEtw, video_Mnvw0GYxI5U,Streaming now at https://abc7chicago.com/watch/live/11064984/.
New law enforcement security bulletins claim ICE agents and facilities are at increased threat of violence from domestic extremists. https://abc7chicago.com/post/ice-chicago-anarchist-website-targeting-agents-facilities-law-enforcement-security-bulletins-say/17953253/
,medical facilities,fda hospitals,fda approve,doctors office,labs,drug manufacturers,Nij9rIory9w,, Business,Health, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_Nij9rIory9w,#FDAFacts
The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices.
Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently.
Read more by searching "Is it really FDA Approved" on fda.gov
https://www.fda.gov/consumers/consumer-updates/10-facts-about-what-fda-does-and-does-not-approve
#FDAFacts #datosdelafda
,1,Federal investigators are trying to determine how an airplane taxied in front of another plane that was attempting to take off. The incident happened at JFK in New York on Friday. Greg Feith, former senior air safety investigator for the NTSB, analyzes the situation.
Read more: https://www.newsnationnow.com/us-news/northeast/faa-close-call-ny-airport/
#JFKAirport #JFK #Flights
"Rush Hour" is a no fluff, no filler newscast hosted by Nichole Berlie featuring up-to-the-minute news drawing from a network of journalists across the U.S. Weekdays starting at 5p/4C.
NewsNation is your source for fact-based, unbiased news for all America.
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,,pLb1f8MBQ-A,, Society, channel_UCQGANpde9Twi2Gn73WpI8SQ, video_pLb1f8MBQ-A,Joliet, Illinois — just forty miles southwest of Chicago — stands at the crossroads of two worlds. On one side, it’s a proud Midwestern city built on steel, limestone, and Route 66 history. On the other, it’s a battleground shaped by decades of gang violence that spill over from Chicago’s South and West Sides.
This documentary dives into the interconnected underworld of Joliet and Chicago’s gang scene, exposing how neighborhood crews, suburban sets, and major organizations like the Vice Lords, Latin Kings, and Gangster Two-Six built pipelines of drugs, guns, and retribution that stretched across Illinois.
We begin with the haunting firebombing of 91-year-old Nicolasa Esquibel, a crime that triggered one of Joliet’s largest gang indictments. From there, we follow the story of Operation Streetsweeper — a 2024 crackdown that swept up twenty-one suspects tied to shootings, narcotics, and weapons trafficking.
The film also revisits the Latin Kings’ downfall in 2016, when “Operation King Kong” exposed their connection to the 2010 killing of Natalie Rodriguez. Meanwhile, the Vice Lords waged their own war, from the 2021 Halloween Massacre that left three people dead, to the 2024 shootout that reignited conflict with rival sets.
From the Gangster Two-Six jewelry heist to gun and cocaine busts across Will County, and even gang recruitment near Joliet Central High School, every case shows how Joliet’s battles are part of a much larger Illinois struggle — one rooted in Chicago’s decades-old gang traditions.
? Featuring:
Vice Lords: Chicago-born organization with Joliet chapters linked to multiple mass shootings.
Latin Kings: One of the Midwest’s most organized gangs, targeted in Illinois’ “Operation King Kong.”
Gangster Two-Six: Ruthless Chicago crew spreading to Joliet’s east side, tied to high-profile armed robberies.
Local Joliet Crews: Regional gangs tied to recruitment, narcotics, and suburban gun wars.
Through police raids, intelligence sharing, and federal partnerships, Illinois law enforcement continues its fight to reclaim control from decades of gang dominance.
#Joliet #Chicago #IllinoisCrime #ViceLords
#LatinKings #GangsterTwoSix #OperationStreetsweeper #TrueCrime
#OperationKingKong #IllinoisGangs #WillCounty #StreetWars
#TrueCrimeDocumentary #GangViolence #ChicagoCrime #LawEnforcement
,1,Legendary Stand-Up comedian, Tommy Davidson, joins Mike Tyson and co-host DJ Whoo Kid to discuss his upbringings, being a part of one of the best sketch shows In Living Color, illustrious career in comedy, and more.
Subscribe to Hotboxin' with Mike Tyson - http://bit.ly/38GAYR5
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,Megyn Kelly,Megyn,Megyn Kelly Show,The Megyn Kelly Show,megyn kelly,megyn kelly show,megyn kelly on,megyn kelly vs,megyn kelly reacts,megyn kelly interviews,megyn kelly full show,megyn kelly full podcast,megyn kelly full episode,the megyn kelly show,megyn kelly news,full megyn kelly,UZL19r9Jmi0,, Politics,Society, channel_UCzJXNzqz6VMHSNInQt_7q6w, video_UZL19r9Jmi0,Megyn Kelly on "horrific" free speech crackdown in UK bringing ARRESTS over "dangerous" posts.
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