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What’s the Difference Between FDA Cleared and FDA Approved?

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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:

  1. 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.”
  2. The FDA looks over the application and tries to make a choice within 90 days.
  3. 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).

  1. 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.
  2. 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.
  3. 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.
  4. 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.

 

As Editor here at GeekReply, I'm a big fan of all things Geeky. Most of my contributions to the site are technology related, but I'm also a big fan of video games. My genres of choice include RPGs, MMOs, Grand Strategy, and Simulation. If I'm not chasing after the latest gear on my MMO of choice, I'm here at GeekReply reporting on the latest in Geek culture.

Astronomy

NASA’s flyby of Europa shows that “something” is moving under the ice

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Europa’s surface has marks that show the icy crust is vulnerable to the water below. The most important thing is that Juno’s recent visit shows what might be plume activity. If this is real, it would let future missions take samples of the ocean inside the planet without having to land.

Even though it’s been almost two years since Juno got the closest to Europa, its data is still being looked at. Even though Juno has been going around Jupiter since 2016, the five pictures it took on September 29, 2022, were the closest views of Europa since Galileo’s last visit in 2000.

Some might say that’s a shocking lack of interest in one of the Solar System’s most interesting worlds, but it could also have been a good way to see how things had changed over time.

Europa is the smoothest object in the solar system because its ocean keeps it from sinking to the surface. Still, it’s not featureless; Juno saw some deep depressions with steep walls that are 20 to 50 kilometers (12 to 31 miles) wide, as well as fracture patterns that are thought to show “true polar wander.

In a statement, Dr. Candy Hansen of the Planetary Science Institute said, “True polar wander occurs if Europa’s icy shell is separated from its rocky interior. This puts a lot of stress on the shell, which causes it to break in predictable ways.”

The shell that sits on top of Europa’s ocean is thought to be rotating faster than the rest of the moon. This is what true polar wandering means. People think that the water below is moving and pulling the shell along with it. Ocean currents are thought to be causing this. The currents are most likely a result of heat inside Europa’s rocky core, which is heated up as a result of Jupiter and its larger moons pulling on Europa and turning it into a large stress ball.

The ocean and ice could stretch and compress parts of the ice, which is how the cracks and ridges that have been seen since Voyager 2 visited were made.

A group under the direction of Hansen is viewing images of Europa’s southern half. The scientist said, “This is the first time that these fracture patterns have been mapped in the southern hemisphere. This suggests that true polar wander has a bigger effect on Europa’s surface geology than was thought before.”

Ocean currents are not to blame for all of Europa’s map changes. It appears that optical tricks can even fool NASA. Hansen said, “Crater Gwern is no longer there.” “JunoCam data showed that Gwern, which was once thought to be a 13-mile-wide impact crater and one of Europa’s few known impact craters, was actually a group of ridges that crossed each other to make an oval shadow.”

But Juno gives more than it takes away. The team is interested in what they’re calling the Platypus because of its shape, not because it has a lot of parts that shouldn’t go together. Ridges on its edge look like they are collapsing into it. The scientists think this might be because pockets of salt water have partially broken through the icy shell.

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The Europa Clipper would find these pockets to be fascinating indirect targets for study, but the dark stains that cryovolcanic activity might have left behind are even more intriguing.

“These features suggest the possibility of current surface activity and the existence of liquid water beneath the surface on Europa,” stated Heidi Becker from the Jet Propulsion Laboratory. There is evidence of such activity in the geysers of Enceladus, but there is still uncertainty regarding whether it is currently happening on Europa.

Engaging in such an endeavor would enable the sampling of the interior ocean to detect signs of life simply by flying through a plume and gathering ice flakes without the need for landing or drilling.

It seems that in the past, there was a significant shift of over 70 degrees in the locations of features on Europa’s surface, although the reasons for this remain unknown. However, at present, polar wander only leads to minor adjustments.

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Astronomy

The Sun emitted the largest solar flare in the past 20 years, resulting in power outages

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Solar Cycle 25 is decidedly more turbulent than its predecessor. The Sun is currently experiencing heightened activity, characterized by solar storms, coronal mass ejections, and geomagnetic storms of unprecedented intensity in recent years. Currently, the sun has emitted its most powerful solar flare to date during this particular cycle.

The flare was quantified as an X8.7, indicating a considerably higher strength compared to the flares emitted last week. The event emitted highly energetic light in the extreme ultraviolet range, which resulted in the ionization of the uppermost layer of the atmosphere. Consequently, a radio blackout occurred over the Americas, adversely impacting aircraft and vessels that depend on signals with frequencies below 30 MHz.

Ionization of the atmosphere causes an expansion, resulting in increased drag on satellites in low Earth orbit. They will require strategic maneuvering to be moved away from Earth. Solar flares have the potential to interfere with satellite communications.

A gif of the Sun yesterday with two bright flashes corresponding to the flares on its limb

Sunspot AR 3664 is where it comes from. Last week, several strong flares were seen coming from this area, including the second strongest of this cycle at the time. The Sun also sent out a number of coronal mass ejections (CMEs), which hit Earth and caused the beautiful auroral display we saw last weekend.

Back then, the sunspot was right on the side of the Sun that could be seen, and anyone could see it. It’s sixteen times wider than Earth! As the Sun turns, the spot is now on its side, so we can only see it from the side. We might have seen a bigger flare if it had happened last week.

“Another X-ray flare was made by Region 3664 as it moved past the western solar limb!!” It was an X8.7 flare this time, the biggest of this solar cycle! NASA’s Space Weather Prediction Center said in a post that any coronal mass ejection (CME) linked to this flare “likely WILL NOT have any geomagnetic effects on Earth due to its location.” “As always, please check our website for news!”

Today, as the CME moves past Earth, there may be a small rise in auroral activity. It’s too bad that nothing as exciting will happen as last Friday.

The solar cycle has a high point and a low point every 11 years. Around the peak, which could happen at any time, the most intense events tend to happen, but every once in a while, there are exceptions. There have been 10 times as many powerful flares this century.

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Astronomy

This planet like Earth is the first one that has been proven to have an atmosphere

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Astronomers have successfully utilized the James Webb Space Telescope (JWST) to observe the presence of an atmosphere around a terrestrial exoplanet, marking the first such discovery beyond our solar system. Despite its inability to sustain life due to its likely magma ocean, this planet could provide valuable insights into the early geological development of Earth, as both planets share a rocky composition and a history of being molten.

Sara Seager, a planetary scientist at the Massachusetts Institute of Technology in Cambridge who was not part of the study, states that the discovery of a gaseous envelope surrounding an Earth-like planet is a significant achievement in the field of exoplanet research. The Earth’s tenuous atmosphere plays a vital role in supporting life, and the ability to detect atmospheres on comparable rocky planets is a significant milestone in the quest for extraterrestrial life.

JWST is currently studying the planet 55 Cancri e, which orbits a star similar to the Sun at a distance of 12.6 parsecs. It is classified as a super-Earth, meaning it is a terrestrial planet slightly larger than Earth. Specifically, it has a radius approximately twice that of Earth and a mass more than eight times greater. The paper published in Nature1 suggests that the atmosphere of the planet is likely to contain significant amounts of carbon dioxide or carbon monoxide. Additionally, the thickness of the atmosphere is estimated to be “up to a few percent” of the planet’s radius.

A mysterious world
55 Cancri e is also not a good place to live because it is very close to its star—about 1.6 times as close as Earth is to the Sun. Still, Aaron Bello-Arufe, an astrophysicist at the Jet Propulsion Laboratory (JPL) in Pasadena, California, and a co-author of the paper, says, “it’s perhaps the most studied rocky planet.” Its host star is bright at night, and the planet is big for a rocky one, so it’s easier to study than other places outside of the Solar System. “In astronomy, every telescope or other tool you can think of has pointed to this planet at some point,” says Bello-Arufe.

55 Cancribe was studied so much that when JWST was launched in December 2021, engineers pointed the infrared spectrometers of the spacecraft at it to test it. As these instruments soak up infrared wavelengths from starlight, they can find the chemical signatures of gases swirling around planets. Then Bello-Arufe and his coworkers chose to look into it more to find out for sure if the planet had an atmosphere.

Astronomers had changed their minds about 55 Cancri a huge number of times before the most recent observations. In 2004, the planet was found. Scientists first thought it might be the center of a gas giant like Jupiter. Researchers looked at 55 Cancri e as it passed in front of its star3 with the Spitzer Space Telescope in 2011. They found that it is a rocky super-Earth, much smaller and denser than a gas giant.

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After some time, scientists found that 55 C was cooler than it should have been for a planet that was so close to its star. This suggests that it probably has an atmosphere. One hypothesis was that the planet is a “water world” with supercritical water molecules all around it. Another was that it has a large, primordial atmosphere mostly made up of hydrogen and helium. But in the end, these ideas were shown to be wrong.

According to Renyu Hu, a planetary scientist at JPL and co-author of the new study, stellar winds would make it difficult for a planet this close to its star to retain volatile molecules in its atmosphere. He says there are still two options. The first was that the planet is completely dry and has a very thin layer of rock vapor in the air. The second reason was that it has a thick atmosphere made up of heavier, less volatile molecules that don’t easily escape.

A better picture
The most recent information shows that 55 Cancrie’s atmosphere has gases made of carbon, which points to option two. Seager says that the team did indeed find evidence of an atmosphere but that more observations are needed to fully understand its make-up, the amounts of gases present, and its exact thickness.

Laura Schaefer is a planetary geologist at California’s Stanford University. She wants to know how the atmosphere of 55 Cancrie affects things below the surface of the planet. The authors of the study say it’s still possible that stellar winds are carrying away parts of the atmosphere. However, rocks melting and releasing gases into the magma ocean could replace the gases.

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