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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

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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Astronomy

Why some physicists believe we live in a black hole

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Black holes are enigmatic entities that, despite our extensive knowledge, continue to perplex our comprehension of physics. Physicists have proposed unconventional hypotheses to address the paradoxes encountered during the study of these phenomena. One hypothesis suggests that these paradoxes indicate that our universe is actually a holographic representation. According to this idea, everything we observe and perceive is encoded at the boundary of our universe, which is a three-dimensional representation of a two-dimensional universe, including time. Moreover, there have been suggestions that this could potentially indicate that our universe exists inside a black hole within a larger universe.

Black holes are regions of space that result from the gravitational collapse of massive stars, exhibiting such intense gravity that even light cannot escape. Their presence presented a challenge when examining them from a thermodynamic perspective. After achieving stability, a black hole’s mass, angular momentum, and electric charge are the only factors that determine its final state.

“According to French astrophysicist Jean-Pierre Luminet’s 2016 review, in classical general relativity, a black hole effectively traps any particle or form of radiation within its cosmic confinement, preventing their escape.” “To an external observer, the moment a material body passes through an event horizon, all information regarding its material properties becomes inaccessible.” Only the updated values of mass (M), angular momentum (J), and electric charge (Q) are retained. Consequently, a black hole engulfs a vast quantity of information.

It may appear straightforward—or at least as straightforward as physics can be. However, if a black hole possesses mass (which is typically substantial), it should theoretically possess a temperature in accordance with the first law of thermodynamics. Furthermore, in accordance with the second law of thermodynamics, it should emit thermal radiation. Stephen Hawking demonstrated that black holes emit radiation, now known as Hawking radiation, which is generated at the boundary of a black hole.

“Hawking subsequently identified a paradox.” “If a black hole undergoes evaporation, a fraction of the information it possesses becomes permanently irretrievable,” Luminet elaborated. A black hole’s thermal radiation does not retain or replicate information about the matter it ate. The irrevocable loss of information contradicts one of the fundamental principles of quantum mechanics. The Schrödinger equation states that in physical systems that undergo changes over time, information cannot be created or destroyed. This property is referred to as unitarity.

This phenomenon is referred to as the black hole information paradox, and due to its apparent contradiction with our existing comprehension of the cosmos, it has been extensively examined and discussed.

Examining the thermodynamics of black holes within the context of string theory led to the discovery of an alternative solution. Gerard ‘t Hooft demonstrated that the total number of independent variables within a black hole is directly proportional to the surface area of its horizon, rather than its volume. This enables the examination of the entropy of a black hole.

“In terms of information, Luminet explains that each bit, represented as either a 0 or a 1, corresponds to four Planck areas. This correspondence enables the derivation of the Bekenstein-Hawking formula for entropy,” Luminet concludes. “To an external observer, it appears that the information regarding the entropy of the black hole, which was previously contained within the three-dimensional arrangement of objects that entered the event horizon, is no longer accessible.” However, according to this perspective, the data is encoded on the flat, two-dimensional surface of a black hole, similar to a hologram. Thus, Hooft concluded that the information consumed by a black hole could be fully recovered through the process of quantum evaporation.

Although it is consoling to know that black holes do not violate the second law of thermodynamics, this has given rise to the unusual idea that a three-dimensional space’s two-dimensional boundary can explain its physics.

It has been suggested that the universe itself could potentially function like a black hole, with all phenomena occurring at its boundary and our observations arising from these interactions. However, this concept does not apply to the space outside of a black hole. This idea is quite unconventional, with some unexpected additions. For example, there is a suggestion that gravity may emerge as a force from entanglement entropy at the boundary.

The theory falls short in its ability to provide a convincing explanation for our universe, as standard physics continues to offer the most accurate description of the observable universe. However, there are valid justifications for why individuals consider it of great importance.

In order for the model to be valid, it is crucial that the Hubble radius of the universe, which represents the radius of our observable universe, is equivalent to its Schwarzschild radius. This refers to the size of a black hole that would form if all the matter within it was compressed into a single point. These two figures are unexpectedly similar, although this could be attributed to a cosmic coincidence.

There are other factors to consider, like this comprehensive chart that indicates the possibility of our existence within a black hole within a larger universe. However, until a theory emerges with substantial evidence and predictions that surpass our current knowledge of physics, we recommend refraining from succumbing to an existential crisis. This applies regardless of whether you perceive yourself as a three-dimensional entity existing within conventional space-time or as a holographic projection originating from a two-dimensional boundary within a larger universe.

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Astronomy

A potential development of the first lunar railway is anticipated within the next ten years

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For people to live on the Moon’s surface permanently, they need to be able to use Moon resources. Not everything can be brought to Earth. But it’s not likely that the base will have everything it needs right there. Some things will need to be moved. It’s not a new idea to have cars (well, buggies) on the Moon, but now scientists are thinking about a very different idea: a railway system that floats.

FLOAT, which stands for “Flexible Levitation on a Track,” is the name of the project. The goal is to make payload transportation that is self-driving, dependable, and effective. As part of its mission, it will move payloads from spacecraft landing zones to the base and from mining sites to places where resources are taken out or where the soil is used for building.

Interesting about the technology is that the tracks are not fixed. Since they are unrolled right onto the lunar regolith, FLOAT doesn’t need much site preparation. Robots that can levitate will be able to move over the tracks. Since they don’t have wheels or legs, they don’t have to deal with the sharp regolith and its damaging power.

There is a layer of graphite on the flexible film track that lets diamagnetic levitation happen, and a flex circuit creates electromagnetic thrust. You don’t have to use the third layer, but if you do, it’s a solar panel that will power the system when it’s in the sun. The robots may be different sizes, but the team thinks that every day they can move 100 tons of stuff over several kilometers.

In phase II, six NASA Innovative Advanced Concepts (NIAC) have been moved forward. FLOAT is one of them. A new way to get astronauts to Mars quickly and an idea for a liquid space telescope are two others. For FLOAT, phase II will be all about designing and building a smaller version of the system that will be tested in a moon-like environment. This will also help us learn more about how the environment affects tracks and robots and what else is needed to make this idea a reality.

In a statement, John Nelson, NIAC program executive at NASA Headquarters in Washington, said, “These different, science fiction-like ideas make up a great group of Phase II studies.” “Our NIAC fellows always amaze and inspire us. This class makes NASA think about what’s possible in the future.”

These projects got $600,000 to keep looking into whether they were possible. As the leader of FLOAT, Ethan Schaler from NASA’s Jet Propulsion Laboratory is in charge. If the system keeps showing what it can do, it could be an important part of life on the Moon by the 2030s.

Phase I projects have also been announced. The ideas include new designs for telescopes, ways to make Mars less dangerous, and even a group of very small spacecraft that could reach our nearest stars in 20 years.

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