The office of the Additional Director General of Foreign Trade (CLA DGFT) has announced an Export Obligation Discharge Certificate (EODC) Camp scheduled from November 11 to 22, 2024. The camp is

A fee created to push oil and gas companies to plug methane leaks could be axed by the incoming Trump administration, hampering efforts to curb the potent greenhouse gas

Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall.

Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors.

As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans.

The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel?
Read more »

The U.S. Food and Drug Administration posted a photo:

Catherine Dasenbrock, director of the U.S. Food and Drug Administration’s National Forensic Chemistry Center, speaks to guests prior to officially reopening the center during a ribbon-cutting ceremony, Sept. 24, 2024, celebrating the completion of the 64,000-square-foot expansion and renovation of the facility in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

U.S. Food and Drug Administration officials and General Services Administration leaders officially reopen the National Forensic Chemistry Center during a ribbon-cutting ceremony, Sept. 24, 2024, highlighting the completion of the 64,000-square-foot expansion and renovation of the center in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

(From left)
Marie Maguire, Assistant Special Agent in Charge, Headquarters Operations, Office of Criminal Investigations, FDA
James Sigg, Deputy Commissioner for Operations and Chief Operating Officer, Office of the Commissioner, FDA
Catherine Dasenbrock, Director, National Forensic Chemistry Center, Office of Inspections and Investigations (OII), FDA
Duane Satzger, Associate Director, Office of Medical Products and Specialty Laboratory Operations, OII, FDA
Katy Kale, Deputy Administrator, GSA
Douglas Stearn, Principal Deputy Associate Commissioner, OII, FDA

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The Orphan Drug Act (ODA) turned 30 this month, demonstrating that good laws really can have an enduring impact. Amidst the celebrations, a reporter asked me a provocative question: can we afford more orphan drugs costing hundreds of thousands of dollars per year? FDA Matters answered “yes.” However, I added a caveat that should worry everyone eager for orphan drugs to succeed. When genomics and personalized medicine become successful, this will multiply the number of rare diseases and the overall cost of orphan drugs, perhaps beyond what the system can bear.

Act now for the best deal on SAS Global Forum 2016 registration. You already know that SAS Global Forum will pay for itself in learning opportunities.

This paper highlights the many enhancements to SAS/ETS software and demonstrates how these features can help your organization increase revenue and enhance productivity.

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"It is estimated that the spotted stem borer and the African stem borer reduce Kenya's maize crop by 13 per cent or 400,000 tonnes annually. Controlling the pest using biotechnology will not only reduce Kenya's food imports, it will also equip the country with new techniques that can be redeployed for other sectors such as drug and vaccine development."

Feb 22, 2024

Professors hear a great deal these days about how hard it is to get our students to listen to, much less to engage with, opinions they dislike. The problem, we are told, is that students are either “snowflakes” with fragile psyches or “authoritarians” who care more about their pet causes than about democratic values such as tolerance, compromise and respect for opposing points of view. Students at Harvard, where I teach, returned from winter break in January to an institution that appeared determined to tackle this problem head-on. An email from the undergraduate dean reminded them that “The purpose of a Harvard education is not to shield you from ideas you dislike or to silence people you disagree with; it is to enable you to confront challenging ideas, interrogate your own beliefs, make up your mind and learn to think for yourself."

May 23, 2024

MEI Fellow Yuree Noh assesses public opinion in Kuwait following the suspension of its parliament.

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The xz Utils backdoor incident reveals that the security of the global internet depends on countless obscure pieces of software written and maintained by even more obscure unpaid, distractible, and sometimes vulnerable volunteers. It’s an untenable situation, and one that is being exploited by malicious actors. Yet precious little is being done to remedy it.

Settlement Overview Video. If you lived at Huronia, Rideau, or Southwestern Regional Centres, you may be eligible to make a claim.

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This #AutismAwarenessMonth we encourage families with special needs to take steps now to plan for their loved ones� futures. Our Director of Advanced Planning, Ruthann Driscoll, discusses the importance of planning to secure long-term security and quality of life for your family. Learn more: http://u.nm.com/1AQBAsN

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Gary Sinise and nearly 100 WWII veterans mark the opening to the newest exhibit at the National WWII Museum. Road to Tokyo: Pacific Theater Galleries, retraces the grueling trail that led from Pearl Harbor to Tokyo Bay. Through personal narratives, artifacts and oral histories, the exhibit tells the story of the American spirit that carried the day.

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Do not hold multiple PAN as it may cost you.A fine amounting Rs. 10,000 may be imposed u/s 272B of the Income Tax Act for possessing multiple PANs or providing incorrect PAN info

Hi everybody.

The question I get most is: "Where do you get your ideas?"

Generally, when I'm asked this question, it's at a book event where it's difficult to answer, because… Well, the answer is long, and complicated, and hard to pin down, and most of the time, I don't really remember how it happened. When an idea starts to arrive, I get to work. I'm not paying attention to how it's happening, or how it would look to an outsider. 

But — a few weeks ago, a new book idea started knocking on the door of my mind. And this time, I decided to pay attention!

What follows is probably the most detailed explanation I'll ever give of where my ideas come from. More specifically, where this particular idea came from, because it's not always the same. But my experience of the past few weeks has been fairly typical for me, and I'll add that there are a few activities I need to engage in every single time, if I want an idea to take root. Namely: PATIENCE. LISTENING. And, LABOR. Book ideas require a certain honed receptiveness, and they require a LOT OF WORK. 

I'm yelling because I'm trying to push back against the idea that ideas simply come to writers. Yes, some parts of ideas come to writers. But when I first get a book idea, what "comes to me" probably comprises about 0.1% of what could properly be called a book idea. Often, it's little more than an inchoate feeling. With patience, listening, and labor, I transform the idea into something I can grasp, and work with.

I'll add that yes, we do hear sometimes of writers whose ideas "simply came to them," fully formed. I'm going to take a guess that (1) this doesn't happen very often, if ever, with books that have complicated structures or plots, and (2) writers who are blessed by ideas in this way probably have a long-honed practice of receptiveness.

Anyway. Warning upfront that this may be a little unstructured, because the process is a little unstructured. It's challenging to describe, and I'm still in the middle of it. But here's what my last few weeks have been like.

A few weeks ago, while watching a TV show that had a certain mood/aura that'd really sucked me in, I found myself drawn to the idea of a story involving three characters. I'm not going to tell you what TV show I was watching, and I'm not going to tell you anything about my three characters, because story ideas are intensely, intensely private. The first time I say anything publicly about it will probably be years from now, if and when this book is ever scheduled for release. But let me try to explain a bit about that moment when the first glimmering of the idea appeared. 

Like I said, I'd been watching a TV show when it happened. But my three characters weren't characters in that TV show. Nor did anyone in that TV show relate to each other the way my three characters seemed to want to relate. Nor did my three characters seem to live in a world like the world of the TV show. The TV show helped to launch the idea at me because of the show's mood and its feeling, and how much I cared about the people in it. But my idea? As is often the case, my idea came from something I saw missing in the TV show. Not missing because there was a flaw in the TV writers' story; I loved their story! But missing (for me and possibly only me) because their story was not the story I would have told.

I think that a lot of my idea seeds come from my adoration of other people's stories, but also from my noticing what's missing in those stories, for me. What story I would've like to have seen told; what characters the story lacked.

Anyway. So this idea of these three characters came to me. But when I say "idea of these three characters," already that sounds more substantial than it was. I knew they were three humans (or humanoids; I didn't know what genre the story was, so they could've been aliens on another planet, for all I knew. In fact, I actively considered whether they might have different biology than ours). I knew they cared about each other, but I didn't know in what way. I knew they were facing a challenge that would strain all of their relationships. I thought they might be grown-ups, but I wasn't sure. I thought I knew at least two of their genders, but I wasn't sure. I knew they lived in a world with magic, but I didn't know what "magic" meant in the context of their world. I didn't know where they lived, or when they lived (past? future? futuristic past? postindustrial future? any of about a hundred other possibilities). I knew a whole lot of things that the characters weren't, and that the world wasn't — which is another way of saying that my sense of what this story was was actually more defined by all the things I knew it wasn't. (Apologies if this is vague. I'm not being intentionally vague! I'll try for some concrete examples: I knew I didn't want to write a story where partway through, someone suddenly discovers they have an inborn power they didn't know they had. I knew I didn't want to write a love triangle. There's a certain kind of high-handed fantasy tone that I knew wasn't right for this story. But I didn't know what I did want yet at this point.)

Really, all I knew was that I seemed to be having an idea.

So, like a writer, I did what I needed to do: 

• I made space in my mind for receptiveness. (I scheduled uninterruptable alone time. I stopped listening to podcasts while I was out walking, and instead, just walked, so my mind could wander. I put aside non-urgent tasks for a while so that I didn't have the feeling of a to-do list hanging over my head. I gave myself permission to wool-gather, to become vague and absent-minded. I set three timers any time I cooked anything so I could feel free to forget I was cooking, but also not burn the house down. I remembered to thank my husband frequently for being willing to live with a space cadet.)
• I thought about what fertilizer might help the idea to grow, especially fertilizer in the form of books, TV, and movies. I put all other books, TV, and movies aside. (I kept watching that same TV show, and I also began reading almost exclusively one writer who had a narrative tone — and also subject matter — that helped me sustain a mood that felt concurrent with the mood of my own idea. Why does this kind of intake help? It keeps my mind in a story space, while also giving me something to bounce my own ideas off of. It's a kind of reading, or watching, that involves a state of constant interactivity and reactivity. Everything I'm consuming becomes about something else that I'm looking for. It's difficult to explain, maybe because it gets back to that inexplicable moment when new ideas form.)
• I made sure that every single time I had any new thoughts relating to my idea, I wrote them down. (This meant making reminders on my phone; sending strings of emails to myself; choosing a notebook where I began to jot things down; sending texts to myself on my husband's phone, if his phone was closer to hand than mine.)
• I looked at my schedule to give myself a sense of if and when I might have a few days soon to put my current writing project aside and give some true, devoted time to this new idea. (I was, and still am, in the middle of revisions of the next Graceling Realm book when this happened, and that was, and still is, my absolute first priority. As exciting and intense as a new idea can be, it can't unseat me from my current object of devotion.)

By chance, last week, I did in fact have some time away from my revision while it was briefly with my editor. I was able to devote an entire week to the new book idea. So, next, I'll try to describe what a week of intense idea-gathering looks like for me! (Though I should say that this will differ from book to book. It's been pretty clear to me from the beginning that this new idea is going to be slow to grow — planning this book will take way more than a week. In contrast, last fall, I found myself with a new and sudden book idea that coincided with the end of another project, so I had some free time and was able to sit down and hammer out the entire book plan, which took only a few days. I think this is because that book was shorter and less emotionally complicated than this new book will be, and was set in a less complex world. Also, at the time, I was absolutely thrumming with the adrenaline and momentum of having just finished a writing project, so book-planning became a way to channel that energy. Often these processes are subject to whatever else is going on in my life.)

So. My week of intense idea-gathering looked a lot like what I've already described — reading, watching TV, but now also with long hours of sitting staring at a blank page and/or lying on my back staring at the ceiling — but with a more specific goal. Namely, I was trying to figure out what my main questions were. For me, every book starts (and continues, as I write) with an extremely long list of questions that I'm trying to find the answers to, but it takes work to figure out what the questions are. The questions can be very different from book to book. And it's essential, at the beginning, to identify what the main questions are.

When I'm first idea-gathering, I use very short notebooks in which I scribble down all my random thoughts as they come (I like using these twenty-page notebooks from Laughing Elephant, because they're short enough not to feel intimidatingly important). Then I have one longer, thicker notebook which is for my more coherent thoughts — my more serious book planning. During my week of active idea-gathering, I came up with the following list of major questions, worthy of being written down in my thick, "serious" planning notebook:

MAJOR QUESTIONS.

• What is magic?
• How does bad human behavior manifest in this world? (for real *)
• Where/what culture does each of them come from? What family?
• How is society governed?
• Who is each of them — as a person and as a power manifestation?
• How is the narrative positioned?
• What is the plot?
• How do humans relate to the rest of the natural world?
• What is gender? (for real *)

* and by societal definition

So. I'm not sure how closely you looked at those questions — but they are pretty gigantic questions! It took me a week to identify all of them. It's going to take me much, much longer to answer them. Which goes back to my point that ideas don't just "come to me." The merest seed of an idea might come to me, and after that, I make the space, and do the work.

As I began to hammer out my questions, I continued to read, watch things, and wool-gather, but with more intense focus. Because now I was also trying to answer these questions as they came. It was interesting to observe the order in which I began to find the answers. Not surprisingly, probably since my novels tend to be character-based, it was the character-based questions that drew me in first. “What is gender" in particular, because I have a sense that in this story, my characters' relationships to gender are absolutely integral to who they are, and I can’t get very far with a book plan if I don’t know who my characters are. I also started to gather some clues about their personalities and their strengths. Enough that after a couple of days, I got to the point where I suddenly knew I needed their names. Names ground everything, and they can also change some things; at a certain point, I can't make any further progress without names. I spent one entire day last week mostly just trying to figure out three people's names. Once I had the names, I was able to return to my questions.

Then, not too long after that, a moment arose where I knew, again quite suddenly, that what I needed next was at least the broad strokes of a plot. If I’m a little scornful about the concept of inspiration — because it’s a concept that dismisses how hard I work! — I do believe in intuition, and also in experience. Intuition and experience told me that I'd reached the point in my planning where the needs of my plot would hold the answer to a lot of my other questions. Like, how this place is governed; what constitutes bad behavior; and even some character things, like what culture each of my characters is from. Sometimes, once you know what needs to happen in a story, it becomes easier to picture the structure of your world. Because a plot comes with needs; once a plot exists, it limits some of your other options. For example, let's say your plot involves a particular kind of government-based corruption. Well, thinking about that corruption will probably start to show you some of your options for the structure of the government. Once you know the structure of the government, you might begin to understand who holds governmental power — which can lead to answers about how families are structured. Which can lead to answers about culture, which can lead to answers about the societal definition of bad behavior, etc.

So. I reached the point where I needed at least a sense of my plot. But: plotting is a HUGE job. I knew it wasn't something I could do in just a few days, and at this point I also knew that I was going to need to return to my revision soon. So, intuition told me that it was time to stop. Not stop being receptive; not necessarily stop reading or watching the helpful things; not stop sending myself emails, texts, and reminders; but stop trying to make any real, meaty, major progress on this book idea. I needed to save the job of plotting for when I next had a stretch of uninterrupted worktime. Maybe another free week or two somewhere, between other projects.

So, I did some final organizing of my notebook. I transferred things into it from other notebooks and I designating a huge number of empty pages in it for future plot thoughts and future character thoughts. I did this even though in this book, as in most of my books, I sense that character and plot will ultimately end up being the same thing, so it's not going to matter much which thoughts I file where. (In other words, most of my plot is going to spring from who my characters are, and many of my characters will spring from the needs of the plot.) But at this messy stage in planning, it's important to me to feel organized. The illusion of organization stops me from feeling as overwhelmed as I probably should be feeling. So I label things, and delude myself that I can contain this messy process inside a nice neat notebook ????. 

I organized my notebook, and then I put it aside. Today I'm still open to thoughts about my new book idea, but it's not my entire worklife anymore... it's more of a promise for the future. It'll probably be good to have it simmering on the back burner for a while. I'll be able to approach it with a new freshness when I sit down with it again one day.

So. I'm not sure how satisfyingly I've answered the question "Where do you get your ideas?" After all, this idea is still very much in progress. I figured out a lot of stuff last week, but mostly what I figured out is a long list of all the things I don't know yet. There will be many, many more workweeks to go before I'll be able to claim that I truly have an idea for a book. 

But this is my best shot at an answer to the question of where my ideas come from! I guess the point I want to convey is this: I don’t necessarily believe in inspiration. But I believe that sometimes a writer will start to get the merest sense of a story that's missing from the world, and find herself wanting to write that story. At that point, if circumstance allows her the time and space to enter a state that is extremely internally-focused and possibly involves a lot of intake (reading, watching other stories), or if not that, at least an extreme level of sensitivity and receptiveness, of seeing, of listening... And if she puts in the work… her idea-seed will start to take root, and grow into a real, workable idea that might one day be the beginnings of a book! 

And of course, every writer does this differently. Many writers don't plan or plot ahead of time. They figure out the idea as they write. So there's no right or wrong way to do it. 

But this is my best explanation of how I do it.

Godspeed to all writers.

As General Hospital welcomes back Lucky Spencer, fans are wondering if he will leave Port Charles once again. Jonathan Jackson’s character came back to the show recently in order to help with Lulu Spencer’s liver transplant. However, the General Hospital spoilers have dropped hints that he will not be staying for long. Without further ado, […]

The post General Hospital Spoilers: What Does Lucky Spencer Want? appeared first on ComingSoon.net - Movie Trailers, TV & Streaming News, and More.

As Donald Trump and Kamala Harris campaign in Pennsylvania on the last day before the presidential election, false claims of voter fraud are spreading. “The truth is, none of these lies have been about election integrity. It’s always been about power,” says Neil Makhija, chair of the board of elections in Montgomery County, Pennsylvania — the battleground state that “could decide the election” — in a video essay featured by The New York Times. Makhija joins Democracy Now! to discuss his work expanding access to the vote and debunking the myth of mass voter fraud.

In the wake of the reelection of Donald Trump, some of the richest people in the world saw their net worths soar as stock prices rapidly shot up. “What was different about this election was how central billionaires were in the entire political discourse,” says The Lever's David Sirota, who joins Democracy Now! to discuss the outsized role of the super-rich in U.S politics, pointing out that both Trump and Kamala Harris campaigned heavily with billionaires, including Elon Musk and Mark Cuban. “These people are not giving money simply out of the goodness of their hearts. They want things. They have policy demands,” Sirota says. “The investors, the donors, like billionaires, are looking for a return on their investment.” Sirota, who previously worked as a communications adviser and speechwriter for the Bernie Sanders presidential campaign, also explains how Elon Musk's influence on Trump’s campaign is a preview of the power he could wield if he ends up appointed to the Trump administration.