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RE: Topical gel Syringe change - plastic to glass

From : Communities>>Regulatory Open Forum
Dear Roy, You do not mention any important functions of the syringe/applicator, other than the Primary Packaging function for which you have identified testing to assess impact. The determination of these functions (e.g. deliverable dose or dose accuracy) could provide important testing to verify that no impact on performance. Also, an assessment on the impact of the change on the usability could be required (particularly if the ergonomics/forces change) or patient risk would be prudent, which [More]




gel

RE: Topical gel Syringe change - plastic to glass

From : Communities>>Regulatory Open Forum
Dear Lee & Spyros, Many thanks for your invaluable advice - really appreciate your time in considering and providing deep insight. Kind regards, Roy Jamieson (BPharm Hons) Regulatory CMC Consultant




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Mystery syndrome similar to Kawasaki disease linked to coronavirus at Children's Hospital Los Angeles

Doctors have recently identified a condition called pediatric inflammatory multi-system syndrome among children who have tested positive for antibodies against COVID-19.






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Thoughts on the Hagel Filibuster and its Political Implications


I’m late to the conversation about whether or not Republican efforts to insist on sixty votes for cloture on Chuck Hagel’s nomination as Secretary of Defense constitutes a filibuster. Bernstein’s earlier piece ("This is what a filibuster looks like") and Fallows’ recent contribution provide good, nuanced accounts of why Republican tactics amount to a filibuster, even if some GOP senators insist otherwise. In short, the duck test applies: If it looks like a duck, swims like a duck and quacks like a duck, then …. it’s a filibuster!

Still, I think there’s more to be said about the politics and implications of the Hagel nomination. A few brief thoughts:

First, let’s put to rest the debate about whether insisting on sixty votes to cut off debate on a nomination is a filibuster or, at a minimum, a threatened filibuster. It is. Even if both parties have moved over the past decade(s) to more regularly insist on sixty votes to secure passage of major (and often minor) legislative measures and confirmation of Courts of Appeals nominees, we shouldn’t be fooled by the institutionalization—and the apparent normalization—of the 60-vote Senate. Refusing to consent to a majority’s effort to take a vote means (by definition) that a minority of the Senate has flexed its parliamentary muscles to block Senate action. I think it’s fair to characterize such behavior as evidence of at least a threatened filibuster—even if senators insist that they are holding up a nomination only until their informational demands are met.

Second, there’s been a bit of confusion in the reporting about whether filibusters of Cabinet appointees are unprecedented. There appears to have been no successful filibusters of Cabinet appointees, even if there have been at least two unsuccessful filibusters against such nominees. (On two occasions, Cabinet appointees faced cloture votes when minority party senators placed holds on their nominations—William Verity in 1987 and Kempthorne in 2006. An EPA appointee has also faced cloture, but EPA is not technically cabinet-level, even if it is now Cabinet-status). Of course, there have been other Cabinet nominees who have withdrawn; presumably they withdrew, though, because they lacked even majority support for confirmation. Hagel’s situation will be unprecedented only if the filibuster succeeds in keeping him from securing a confirmation vote.

Third, using cloture votes as an indicator of a filibuster underestimates the Senate’s seeping super-majoritarianism. (Seeping super-majoritarianism?! Egads.) At least two other recent Cabinet nominations have been subjected to 60-vote requirements: Kathleen Sebelius in 2009 (HHS) and John Bryson (Commerce) in 2011. Both nominees faced threatened filibusters by Republican senators, preventing majority leader Reid from securing the chamber’s consent to schedule a confirmation vote—until Reid agreed to require sixty votes for confirmation. The Bryson unanimous consent agreement (UCA) appears on the right, an agreement that circumvented the need for cloture. Embedding a 60-vote requirement in a UCA counts as evidence of an attempted filibuster, albeit an unsuccessful one. After all, other Obama nominees (such as Tim Geithner) were confirmed after Reid negotiated UCAs that required only 51 votes for confirmation, an agreement secured because no Republicans were threatening to filibuster.

Finally, what are the implications for the Hagel nomination? If Republicans were insisting on sixty votes on Senator Cornyn’s grounds that “There is a 60-vote threshold for every nomination,” then I bet Reid would have been able to negotiate a UCA similar to Sebelius’s and Bryson’s. But Hagel’s opponents see the time delay imposed by cloture as instrumental to their efforts to sow colleagues’ doubts about whether Hagel can be confirmed (or at a minimum to turn this afternoon’s cloture vote into a party stand to make their point about Benghazi). Of course, it’s possible that the time delay will work to Democrats’ benefit if they can make headlines that GOP obstruction puts national security at risk. (Maybe Leon Panetta should have jetted to his walnut farm to make the point before the cloture vote.) Whatever the outcome, the Hagel case reminds us that little of the Senate’s business is protected from the intense ideological and partisan polarization that permeates the chamber and is amplified by the chamber’s lax rules of debate and senators’ lack of restraint. Filibustering of controversial Cabinet nominees seems to be on the road to normalization—even if Hagel is ultimately confirmed.

Authors

Publication: The Monkey Cage
Image Source: © Kevin Lamarque / Reuters
      
 
 




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The reimagination of downtown Los Angeles


Los Angeles has long been a city associated with the common ills of urban excess: sprawl, homelessness, and congestion. More charitable descriptions paint it as West Coast paradise, boasting sunshine and celebrities in equal measure.

A three-day visit to downtown Los Angeles exposed the nuances behind these stereotypes. Hosted by the Los Angeles Downtown Center Business Improvement District, which is focused on strengthening downtown as an innovation district, our visit began as a real estate tour but quickly revealed regeneration and innovation activity that confounded our expectations. 

Downtown LA (DTLA)’s innovation district focuses not just on tech firms but also on historic LA industry strengths like fashion, design, and real estate. LA may have sat in the shadow of the Silicon Valley tech boom, but it appears to be revitalizing in time for the convergence economy, in which tech is no longer a separate sector but ingrained in all forms of economic and creative activity.

And at a time where firms are revaluing proximity, vibrancy, and authenticity, DTLA could not be in a better place. While a number of U.S. cities subjected their downtowns to a range of urban renewal initiatives, the urban fabric of DTLA is largely intact. Vibrant areas like South Broadway feature boutique hotels, a dozen theatres, and clothing stores and bars that exist in historic infrastructure like reclaimed theatres. There is an urban feel that is authentically LA.

The initial renaissance of DTLA began in the late 1990s, after the residential units within its 65 blocks had dwindled to just 10,000.

Along with transportation improvements, permissive planning policies such as adaptive reuse—which allowed commercial buildings to be converted into residential use—were instrumental in increasing DTLA’s residential population. Since 1999, the residential population and housing units have tripled. With new bars and restaurants springing up on every corner, it is no surprise that three-quarters of DTLA’s current residents are aged between 23 and 44.

Building on this residential surge, an increasing number of businesses are now setting up or relocating downtown.

DTLA office space has not always been an easy sell. Employers balk at the prospect of subjecting their workforce to the punishing commute. And Bunker Hill and the adjacent Financial District, the epicenter of the central business district, offers little more than unpopulated plazas and cubicled office space.

DTLA has worked to serve its newfound residential population and attract more workers and companies by retrofitting buildings to modern aesthetic standards. The exposed brickwork and ceiling equipment of many DTLA offices like those of Nationbuilder, an online platform used for political and civic campaigns, is not just a statement of style but a conscious decision to make downtown office buildings feel hospitable to creative firms. The BLOC, a 1.9 million square foot retail development, is essentially a mall that has been turned inside out, with the roof removed to reveal an open air plaza, unrecognizable from the fortress-style building that once sat in the same spot.

While downtown’s office blocks are a fantastic asset in attracting innovation activity, the area also boasts a vast amount of warehouse space. These larger footprints, most often used for textile or food production, are attracting a range of activities that require space or, in the case of Tesla’s Hyperloop, secrecy. Such industrial firms are interspersed with new art galleries and a historic knitting mill, proof of the area’s artistic heritage.

The individuals leading the drive for a DTLA innovation district, such as Nick Griffin, director of Economic Development for the Downtown Center Business Improvement District, are realistic about challenges, such as the lack of quality public space, and proactive in leveraging existing assets, such as the large supply of creative office space.

These efforts and LA’s distinctive industry strengths are combatting one of the biggest challenges to attracting businesses downtown: the strength of competing areas like Silicon Beach, which includes Santa Monica and Playa del Rey and offers an established tech ecosystem alongside an attractive location.

Another challenge? Like many U.S. cities, LA bears the scars of suburban sprawl and a legacy of under investment in public transportation. Congestion is a constant complaint.

But here too LA is making progress.

In November, Angelinos will vote on an extension of Measure R—a 2008 ballot initiative raising the sales tax to fund core transportation projects—to provide sustainable funding for transportation infrastructure and improve access to the city center through the metro system.

Other ambitious projects, such as the Regional Connector, a light rail subway through the middle of downtown, will have a profound effect on the area's connectivity. This project is not just about getting people to and from downtown—it will also have a transformative effect on public space. The city is working with Project for Public Spaces to redesign one of the Connector’s hubs, Pershing Square, with the aim of providing a public space where employees and residents can convene and collaborate.

Connectivity will play a vital role in the continuing success of DTLA’s resurgence. But the DTLA innovation district’s main opportunity lies in better serving and connecting the people who make it work. With hometown authenticity and civic commitment, DTLA is on its way to creating a city center that is greater than the sum of its parts.

DOWNTOWN LA IN NUMBERS

Size: Approx 8.6 sq. miles

Major districts: Civic Center, Bunker Hill, Financial District, South Park, Fashion District, Jewelry District, Historic Core, Little Tokyo, Exposition Park, Toy District, Central City East, Arts District, City West, Chinatown, and Central Industrial District

Residential population: 60,600
66% of residents are between the ages of 23 and 44

Average median household income: $98,000

Education status: 79% of residents hold a college degree

Average workday population: 500,000


Photo Credit: Hunter Kerhart

Authors

  • Kat Hanna
  • Andrew Altman
Image Source: Hunter
      
 
 




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MSNBC debate moderators largely ignored people of color

In the fifth Democratic presidential debate in Atlanta, Georgia, debate moderators promised at the outset that they would talk about race and public policy. They absolutely failed to deliver. Despite several candidates mentioning issues related to race early in the debate, the MSNBC moderators waited until 90 minutes into a two-hour debate to ask the first…

       




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Double tipping points in 2019: When the world became mostly rich and largely old

When it comes to economic development, positive change is typically gradual and only noticeable over long periods of time; by contrast negative developments—economic crises—are often rapid and spectacular. This creates a biased narrative that focuses on negative news, while positive trends go unnoticed because they are less dramatic. In this blog, amid an atmosphere of…

       




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When the champagne is finished: Why the post-Paris parade of climate euphoria is largely premature

The new international climate change agreement has received largely positive reviews despite the fact that many years of hard work will be required to actually turn “Paris” into a success. As with all international agreements, the Paris agreement too will have to be tested and proven over time. The Eiffel Tower is engulfed in fog…

       




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Dr. Michel Gelobter on Nukes, Republicans, Tech, and the Future of Energy (Podcast)

After seven years in government, seven years in non-profits, and seven years in business, Michel Gelobter jokes that he's headed for the clergy next. And why not? He's led Redefining Progress, been a professor at Rutgers, and run environmental quality




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Los Angeles wants to ban the sale of fur

City council voted unanimously this week to support a ban.




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Watch 50,000 Honeybees Being Removed from Los Angeles Home (Video)

What happens when you find bees have made your home into their hive? You call Mike 'The Bee Guy' and document it their removal.




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200 evangelical scientists ask Congress to pass climate legislation

Two hundred evangelical scientists recently wrote a letter to Congress making the religious case for passing climate change legislation.




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Evangelical Christians call on Obama to protect public lands from oil and gas leasing

Rev. Richard Cizik and the nonprofit New Evangelical Partnership for the Common Good have released a video message to President Obama calling on him to do more to protect public lands from destruction by private industry.




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Montreal may ban wood-fired ovens. Is this the end of the classic Montreal bagel?

Wood smoke is a huge source of particulate pollution and really shouldn't be in residential neighbourhoods. But the flavour...




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Angelina Jolie and Kids Love to Eat Crickets

Angelina Jolie has inadvertently (or perhaps by design) added "Ambassador for Insect Proteins" to her credentials as a do-gooder. In an interview about her Louis Vuitton ad (you remember, the one




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Silver nanoparticles in porous gel becomes bacteria-killing sponge for water purification

A new cheap, lightweight sponge-like gel can quickly and efficiently disinfect drinking water for disaster victims.




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Ferran Adrià's elBulli Restaurant Aims for Zero Emissions with Architect Enric Ruiz-Geli's Smartgrid

Image credit: El País According to El País on sunday, celebraty chef Ferran Adrià is plotting a zero emission premises for his restaurant elBulli on the coast of Catalonia, Spain. The 2010 chef of the decade (nominated by The Restaurant magazine) closed




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340 Ton Rock Levitates Above the Ground in Los Angeles

It's a 340 ton rock, balancing over a crevice...forever.




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Aloe vera gel could be your new favorite moisturizer

It's good for so much more than treating sunburns.




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Oh no! Argentina's Magellanic penguin chicks are being killed by global warming

Small changes in weather can have big consequences for many animals, including the beautiful Magellanic penguin found at the tip of South-America.




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This supportive housing project in Los Angeles could be the future of the construction industry

You have heard of "fast fashion." Get ready for fast architecture in container-sized modules.




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Photo: Gelada baboon is regal in the winter sun

Our photo of the day comes from "The Wild Place Project."




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Angels, Reindeers, Pigs and Christmas Trees; sustainable wood decoration by Lovi

more images below Matteria, good design+smart materials online store, suggest a spicy Christmas this year, without forgetting the environment. Apart from the gorgeous cork advent candle holder, the cosy Finnish red felt slippers, and giftbags to spoil




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Siege of smog grips Los Angeles

With 58 straight days (and counting) of unhealthy air, officials are urging some to stay inside.




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Bjarke Ingels Group and Toyota are building a wild, woven and wooden city of the future

It's actually rather elegant and understated for the Danish superstar.







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St. Jude Children's Research Hospital® to honor legendary Hispanic TV personality Cristina Saralegui at upcoming FedEx/St. Jude Angels and Stars Gala - Celeb Gala B-roll

Miami Gala celebrity B-roll for download




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Jorge Narvaez, el embajador de fuerza de milk life, apoyó la campaña “Somos Fuertes” con una experiencia musical y una donación a un centro YMCA de Los Angeles - La fuerza de la familia

Jorge Narvaez habla sobre la unión y la fuerza de la familia



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St. Jude Children's Research Hospital® to honor legendary Hispanic TV personality Cristina Saralegui at upcoming FedEx/St. Jude Angels and Stars Gala - Celeb Gala B-roll

Miami Gala celebrity B-roll for download




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Trump's tariff threats against China are 'largely bluster': Charles Schwab

It will be difficult for U.S. President Donald Trump to backtrack on the U.S.-China "phase one" trade deal after previously lauding it as "the best deal ever made", says Jeffrey Kleintop of Charles Schwab, adding that March trade data shows a pickup in U.S. exports to China.




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Longtime bull Jeremy Siegel: March coronavirus swoon in stocks 'definitely going to be the low'

"I think 2021 could be a boom year. With the liquidity that the Fed is adding, unprecedented. It could be a really good year," the Wharton School professor told CNBC on Friday.




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Wharton's Jeremy Siegel declares end to the 40-year bull market in bonds

Wharton finance professor Jeremy Siegel expects the interest rate on bonds and inflation to significantly rise over the next several years.




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Wharton's Jeremy Siegel on why historic April job losses aren't impacting stocks

Jeremy Siegel, finance professor at the University of Pennsylvania's Wharton School, joins "Squawk Box" to discuss the April jobs numbers and what the data means for the U.S. economy.




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Booking Holdings CEO Glenn Fogel on impact of coronavirus on travel

Glenn Fogel, CEO of Booking Holdings, joins "Squawk on the Street" to discuss the company's Q1 earnings results and how coronavirus has stalled travel plans globally.




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Startup in India Eligibility and Benefits and Angel Tax Exempt

Startup in India Eligibility and Benefits & Angel Tax Exemption




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S. Korea returns largely to normal as Covid-19 cases slow to a trickle

South Korea returned largely to normal Wednesday as workers went back to offices, and museums and libraries reopened under eased social distancing rules after new coronavirus cases dropped to a trickle.





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Lime Hotel Gelendzhik - на майские с детьми на море

Отдыхали с мужем в мае 2019 Источник: 100 Дорог




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Friday Polynews Roundup — Triad storyline on "The Connors," Black Poly Nation gets TV rep, loving polyfamily profiles, community dreams, and evangelical worry that this all hits too close to home



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George McEachran of England battles for the ball with Cesar Gelabert of Spain

KOLKATA, INDIA - OCTOBER 28: George McEachran (L) of England battles for the ball with Cesar Gelabert of Spain during the FIFA U-17 World Cup India 2017 Final match between England and Spain at Vivekananda Yuba Bharati Krirangan on October 28, 2017 in Kolkata, India. (Photo by Buda Mendes - FIFA/FIFA via Getty Images)




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Joel Latibeaudiere of England battles for the ball with Cesar Gelabert of Spain

KOLKATA, INDIA - OCTOBER 28: Joel Latibeaudiere of England battles for the ball with Cesar Gelabert of Spain during the FIFA U-17 World Cup India 2017 Final match between England and Spain at Vivekananda Yuba Bharati Krirangan on October 28, 2017 in Kolkata, India. (Photo by Buda Mendes - FIFA/FIFA via Getty Images)




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George McEachran of England battles for the ball with Cesar Gelabert of Spain

KOLKATA, INDIA - OCTOBER 28: George McEachran (C) of England battles for the ball with Cesar Gelabert of Spain during the FIFA U-17 World Cup India 2017 Final match between England and Spain at Vivekananda Yuba Bharati Krirangan on October 28, 2017 in Kolkata, India. (Photo by Buda Mendes - FIFA/FIFA via Getty Images)




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Morgan Gibbs White of England and Cesar Gelabert of Spain in action

KOLKATA, INDIA - OCTOBER 28: Morgan Gibbs White of England and Cesar Gelabert of Spain in action during the FIFA U-17 World Cup India 2017 Final match between England and Spain at Vivekananda Yuba Bharati Krirangan on October 28, 2017 in Kolkata, India. (Photo by Tom Dulat - FIFA/FIFA via Getty Images)




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Marc Guehi (L) and Angel Gomes of England celebrate after the FIFA U-17 Worl

KOLKATA, INDIA - OCTOBER 28: Marc Guehi (L) and Angel Gomes of England celebrate after the FIFA U-17 World Cup India 2017 Final match between England and Spain at Vivekananda Yuba Bharati Krirangan on October 28, 2017 in Kolkata, India. (Photo by Buda Mendes - FIFA/FIFA via Getty Images)




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Angel Gomes of England celebrates with the FIFA U-17 World Cup trophy

KOLKATA, INDIA - OCTOBER 28: Angel Gomes of England celebrates after the FIFA U-17 World Cup India 2017 Final match between England and Spain at Vivekananda Yuba Bharati Krirangan on October 28, 2017 in Kolkata, India. (Photo by Buda Mendes - FIFA/FIFA via Getty Images)