Astronomy
What’s the Difference Between FDA Cleared and FDA Approved?
The Food and Drug Administration (FDA) plays one of the most important roles in public health in the United States. It oversees many everyday items that people use. You might hear the terms “cleared” or “approved” used to describe these goods, but what do they really mean? Is one different from the other?
There are a lot of different things that the FDA can clear or approve, from certain foods and cosmetics (though they don’t actually accept cosmetics) to drugs and biologics like vaccines. It might not seem like a big deal if a product is cleared or accepted, but they are actually two different things.
Which method is needed also depends on the product. For example, all new drugs and biologics for humans need to be approved. The process that medical devices go through is based on how dangerous they might be. There are three groups of medical devices based on their level of risk: category 3 devices usually need approval, category 2 devices usually need clearance, and category 1 devices usually don’t need either.
FDA okayed
Getting FDA clearance normally takes the least amount of time—within 90 days of submission, at the very least—because it doesn’t require as many tests as getting approval. Companies don’t have to prove that their product is safe and effective; instead, they have to show that it is “substantially equivalent” to a product that has already been cleared or passed.
The act of clearance
Imagine that you are the inventor of a brand-new medical gadget. You can come up with anything crazy or dull. If it’s not too risky, you won’t need permission. Here’s what you need to do:
- Fill out an application called a 510(k), also known as a premarket notification. The different parts of this application “must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.”
- The FDA looks over the application and tries to make a choice within 90 days.
- The product is cleared to be sold in the US if it is found to be as safe and useful as the device it is being compared to.
Approved by FDA
Manufacturers must get “premarket approval” for high-risk (Class III) medical equipment, new drugs and biologics for humans, and other products. This is a much longer and stricter process.
“A company must demonstrate that its drug or biological product is safe and effective for the intended use and that it can manufacture the product to federal quality standards,” says the FDA.
When a product is approved, it means that the FDA is happy with its safety and effectiveness (how well it does what it’s supposed to do).
The process of approval
Let’s say you’ve come up with a new drug this time (of the pharmaceutical kind, of course). At this point, you should have done a lot of testing in the lab and on animals over the past few years, though the animal testing might not last much longer.
Then it’s time to get the first FDA approval through the Investigational New Drug process. This means sending in the results of your studies so far, along with information about any side effects seen in animals and how you plan to run the human trials.
If it’s okay, you can go straight to clinical studies. Following the data showing that the drug is safe and successful for its intended use, the next step is to submit a New Drug Application (NDA).
- Send in the application. The FDA says that this must include all the information about a drug, from proof that it is safe and effective in all testing steps to how it should be labeled.
- The FDA looks at the proof; if the entry is missing something, it won’t be sent in. The agency checks to see if the drug is safe and effective for its intended use, if the benefits are greater than the risks, and if the labeling and production process are correct.
- The Food and Drug Administration (FDA) makes a choice after 6 to 10 months. If there is enough evidence, the drug can be sold in the US.
- The FDA will keep an eye on the drug after it’s on the market because there’s only so much safety information that can be gathered before it’s approved.
That’s a pretty long process, but there are times when it can be sped up. For example, the Accelerated Approval and Fast Track programs can speed up the process for products that can treat dangerous or life-threatening diseases.
Emergency Use Authorizations (EUAs) can be given when “among other criteria, there are no adequate, approved, and available alternatives” based on the best evidence that is currently available. This was the case for some COVID-19 vaccines, and it is not the same as getting FDA clearance. The FDA says that these can be taken away or changed based on further review of the existing data.
What makes them different?
It’s helpful to know more about the clearance and approval processes in order to understand how regulated goods get to the market, but here are the three most important differences:
- Sometimes it takes a lot longer to get approval than to get clearance.
- Based on the type of product, some items need to be approved, while others can be cleared right away.
- Level of scrutiny: For clearance, a product must be similar to one that already exists, but for acceptance, it must have evidence to back it up for years.
Astronomy
Witness the rare celestial event of Mars and Jupiter reaching their closest proximity in the sky this week, a phenomenon that will not occur again until 2033.
Mars and Jupiter will be only 0.3 degrees apart in the sky on August 14. From our point of view, this passage is very close. If you miss it, you won’t be able to see another one until 2033.
When two objects pass each other in the sky from our point of view, this is called a conjunction. Every time two planets came together, the closer one would block out the other because they would all be moving in a perfectly flat plane. The orbits of the planets are slightly different from those of the other planets, though, so they move slightly to the north and south of each other. Every time, that gap is a different size.
When two things happen close together, the results are especially stunning. Jupiter and Saturn were close enough to each other in 2020 that they could be seen in the same field of view through a telescope. This is a treat for people who like to observe the sky.
Being 0.5 degrees wide, the full moon will fit in any view that can hold the whole moon. This pair will also look good before and after the full moon.
But even with the naked eye, a close conjunction can make the sky look even more amazing. The contrast between the red of Mars and the white of Jupiter will be especially striking. However, Mars’ brightness changes a lot. When it’s at its brightest, it’s about the same brightness as Jupiter. Right now, it’s 16 times less bright. They are so bright that, unless there are clouds, you should be able to see them from all but the dirtiest cities.
Most people in the world will miss this sight, though, because they can’t see the pair of planets in the evening from anywhere on Earth. The exact time they rise depends on where you live, but it’s usually between midnight and 3 am. To see this, you will mostly need to get up before astronomical twilight starts so that you have time to get through the thickest part of the atmosphere.
For people in Europe, Africa, west Asia, and the Americas, the closest time will be 14:53 UTC, which is during the day. The mornings before and after, though, will look almost as close.
Mars and Jupiter meet about every two and a half years, but the most recent one was almost twice as far away and could only be seen in the morning. In 2029, the gaps will be just under two degrees. The next one will be even wider, at more than a degree.
When planets are close to each other, that doesn’t always mean that their distance from each other is very small. Mars has been around the Sun for 687 days, but it is now less than 100 days past its perihelion, which means it is closer than usual. Even though Jupiter is a little closer than usual, it’s not really that close. To be as close as possible to each other, Mars has to be at its farthest point, and Jupiter has to be at its closest point. So this one is not unusual.
But if you want to see something beautiful, you will have to wait more than nine years to see it again.
Astronomy
It may not be long before we find “Earth’s Twin”
To figure out if there is life in other parts of the universe, we start with Earth, where there is life now. Finding another Earth is a good way to find aliens. We have found more than 5,000 exoplanets, but we haven’t found Earth’s twin yet. This could change soon, though. Here comes the PLATO mission from the European Space Agency (ESA).
What does PLATO stand for? It stands for PLAnetary Transits and Oscillations of stars. Its goal is very clear. It will look for nearby stars like the Sun that might have habitable worlds like Earth.
“One of the main goals is to find a way to compare Earth and the Sun.” The size of Earth is in the habitable zone of a star like the Sun. “We want to find it around a star that’s bright enough that we can really figure out how heavy it is and how big it is,” Dr. David Brown from the University of Warwick told IFLScience. “If you like, that’s our main goal.”
The telescope is not only an observatory for looking for planets, but it is also an observatory for collecting data on a huge number of stars. The mission team thinks that the fact that it can do both is a key part of why this telescope will be so important.
“You have two parts of the mission.” One is exoplanets, and the other is the stars. “From a scientific point of view, I think it’s pretty cool that these two parts are working together to make the best science we can,” Dr. Brown said.
One of the secondary goals is to make a list of all the planets that are Earth-like and all the star systems that are out there. One more goal is to find other solar systems that are like ours. Even though we don’t know for sure if our little part of the universe is truly unique, it does seem to be different from everything else.
Dr. Brown told IFLScience, “We have a bunch of other scientific goals.” “Really, how well do we know how planetary systems change and grow over time?” Planetary systems are something we’re trying to understand as a whole, not just one planet at a time.
PLATO is different in more ways than just the goals. It is not just one telescope. In fact, it’s made up of 26 different ones. Two of the cameras are fast, and the other 24 are normal cameras set up in groups of six with a small gap between them. This makes the telescope work better, has a wider field of view, and lets you quickly rule out false positives.
It can be hard to tell which of the things you find when you transit exoplanets are real and which ones are not. With the help of several telescopes, we were able to block out some of the mimics that we would have seen otherwise. “Plus, it looks pretty cool,” Dr. Brown said with excitement. “This big square with all of these telescopes pointing at you looks really cool!”
This week, Dr. Brown gave an update on PLATO at the National Astronomy Meeting at the University of Hull. The telescope is being put together and has recently passed important tests. There are no changes to the planned launch date for December 2026. An Ariane 6 rocket, the same kind that made its first launch last week, will take off from French Guiana.
Astronomy
You can watch and listen to gravitational waves coming from everywhere in the universe
Gravitational waves can be turned into sound very easily. The little chirp changes into little sounds as soon as the blocks hit each other. One of those chirps is my ringtone when my phone has sound, which doesn’t happen very often. The people at Audio Universe have now made the gravitational wave data even better.
In a 3D video, the sounds of gravitational waves hit you from the direction in the sky where it is thought they came from. The sound effects and visualization are both great. There are tiny vibrations in space-time that can hit you as you move your mouse, phone, or VR headset.
Like other sonification projects, it gives blind and visually impaired people a way to get involved in astronomy. It works well with other methods like the Tactile Universe. But that’s not the only reason why they do it.
“We want to do this for three reasons.” It helps researchers look into big, complicated datasets with lots of dimensions. It could be used to make educational materials that are immersive and interesting. Rose Shepherd from Newcastle University says, “It can also make astronomy easier for more people to understand, which is an important thing.” “Making things easier to get makes them better for everyone.”
Being able to listen to the emission lines of celestial objects is one of the most interesting things about sonification for research. As an object moves, its light spectrum peaks spread out, and sonification can make something that is barely noticeable to the eye seem very clear to the ear.
This is helpful in more than one field, though. The group has thought about how adding sound to different datasets could make them better. Warming Stripes is a cool example of this. This is a simple image that shows changes in temperature over time by using a series of stripes, from blue to red. The stripes on the right side get redder as we move from the left to the right. The left side shows decades ago. It is great to see how the climate crisis is getting worse, and now sound adds a little more to it.
“By adding sounds, it can give your data an emotional meaning.” Shepherd explained, “You can use that to show the data how you feel.” “We didn’t mean for the Warming Stripes sonification to make people feel stressed, but it was interesting to see how they reacted instead of just watching the video.”
Audio Universe is making a sonic toolkit that many people can use to make their own resources.
She gave a talk about the audio universe at the National Astronomy Meeting at the University of Hull this week.
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