Connect with us

Astronomy

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

blank

Published

4 weeks ago

on

blank

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.

 

Post Views: 39
Related Topics:
blank

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.

Continue Reading

Astronomy

The PS5 next-gen update for Fallout 4 is now available to be accessed by PS Plus subscribers

blank

Published

6 hours ago

on

April 29, 2024

By

blank

Recently, we reported on the confusion that ardent Fallout fans were having playing the original PS5 version of Fallout 4, which was a result of Amazon’s outstanding adaptation. Individuals who have access to either PS Plus Extra or Premium are now able to upgrade at no cost, as a minor update was released during the weekend.

PSLS has observed that the problem has been resolved, as players are now able to access the next-generation version of the game. Both physical and digital purchasers are eligible for the upgrade, although physical owners will require their discs for the process.

Regrettably, only individuals who obtained Fallout 4 through the now-discontinued PS Plus Collection will be eligible for the upgrade. This decision is consistent with Sony’s current policies, which makes it less unexpected. It is likely that much of the confusion arose because players may have forgotten the precise origin of their digital copy of Fallout 4.

Can you confirm that you can get the PS5 version of Fallout 4 through PS Plus? Talk about how to handle the tricky world of digital rights ownership in the comments section below.

Post Views: 3
Continue Reading

Astronomy

What is the most terrifying communication that humanity could receive from outer space?

blank

Published

5 days ago

on

April 24, 2024

By

blank

If there are extraterrestrial civilizations within a reasonable distance capable of detecting our unintentional transmissions, there exists a possibility, albeit small, that among the initial signals they intercept, they could receive the commencement of the 1936 Olympic Games. Therefore, in the unlikely event that they do receive these signals, we might come across a speech by Adolf Hitler during our first encounter with an alien species.

“Naturally, this was not the initial transmission,” clarified Seth Shostak, a senior astronomer at SETI, during an interview with RealClearScience. “However, it was emitted at a sufficiently high frequency to penetrate the ionosphere.”

In the movie Contact, this ultimately became the initial communication that mankind received from an extraterrestrial society. The entities promptly returned the signal to Earth, unaware of the profound consequences that transmitting broadcasts of Adolf Hitler from outer space would have on the targeted species they were endeavoring to establish communication with. It is similar to greeting a random person and then unintentionally reciting a chapter from Mein Kampf.

Fortunately, it is highly likely that we won’t encounter this issue because extraterrestrial civilizations shouldn’t be able to distinguish the signal strengths.

“The power consumption would have been minimal, and the antenna used would not have had a specific direction,” Shostak elaborated. “The notion that extraterrestrial beings might intercept it is highly improbable.”

However, it is possible that we may receive significantly more alarming initial communications, as individuals have been deliberating on X (Twitter) and Reddit.

It appears that people are primarily focused on receiving warnings from extraterrestrial civilizations right now, possibly as a result of a recent unnamed television series.

What would be the scariest message humanity could receive from outer space?
byu/silly_vasily inAskReddit

According to certain proposed resolutions to the Fermi Paradox, which ask why we haven’t detected any signs of advanced extraterrestrial civilizations, the explanation is that these civilizations are intentionally concealing their presence due to the apprehension of their own annihilation.

Another concern is the possibility of receiving an unclear message that extraterrestrial beings will provide us with limited information, apart from the fact that they are en route.

What would be the scariest message humanity could receive from outer space?
byu/silly_vasily inAskReddit

One theory, called the Zoo Hypothesis, is related to this topic. The theory posits that extraterrestrial beings possess knowledge of our existence but deliberately confine us within a designated “zoo” to allow for our evolutionary and societal development. This parallels humanity’s practice of preserving certain areas as nature reserves and refraining from engaging with uncontacted tribes. Based on this hypothesis, it is possible that we may receive contact once we have reached a satisfactory level of technological and societal development and potentially be accepted into a community of other galaxies.

Although there is a prevailing apprehension that initiating communication with an extraterrestrial civilization will probably elicit fear due to humanity’s historical tendency to fear the unfamiliar, there is a potentially more alarming notion.

Post Views: 8
Continue Reading

Astronomy

Orbex’s recent funding could expedite the launch of its Prime microlauncher into space

blank

Published

2 weeks ago

on

April 18, 2024

By

blank

Orbex, a small launch company based in the UK, got more money from backers, including Scotland’s national bank. The company is now getting ready for its first orbital launch, but the date for that mission has not yet been set.

With its start in 2015, Orbex is one of only a few companies in Europe racing to make the next generation of launch vehicles. The retirement of the Ariane 5 and big delays to the Ariane 6 and Vega C rockets have left a huge gap that these companies are trying to fill. Without these vehicles, there is almost no native launch capacity coming out of Europe.

But Orbex also has a chance because of his absence. The company is working on what is sometimes called a “microlauncher.” It is a two-stage vehicle called Prime that is only 19 meters tall and can take up to 180 kilograms of payload. Rocket Lab’s Electron is the most similar. It’s only a meter shorter, but it can take up to 300 kilograms.

The fact that Orbex is small is not a problem for the company. In fact, Orbex CEO Philip Chambers told TechCrunch via email that the company is seeing “positive market conditions” for its product.

“There is a pent-up demand for sovereign launch capabilities,” he said. “We are seeing an exponential growth of satellites being launched into LEO, and demand for launch is far exceeding supply. At the moment, it’s not possible to launch a single kilogram from Europe.” “We will let European customers choose how to launch their own payloads and let them launch European payloads from European soil.”

Prime will take off from a new spaceport being built with money from the UK’s national space agency in Sutherland, which is in northern Scotland. The end goal is to use a patented recovery technique that the company calls REFLIGHT. This is an interstage device that sits between the rocket stages. When the booster comes off, four “petals” will unfold and, along with a parachute, create enough drag for a soft landing in the ocean.

It’s possible that a bigger car will be made in the future, but Chambers made it clear that Prime was the company’s top goal. He did say, though, that many of the rocket’s main technologies could be used with bigger packages.

Considering the laws of physics, it would be logical for Orbex to explore the option of using larger vehicles in order to compete on cost per kg.

The company is starting its Series D round with £16.7 million ($20.7 million) in new funding, including investments from Octopus Ventures, BGF, Heartcore, EIFO, and other contributors. Following the closure of a £40.4 million ($50 million) Series C in October 2022, Orbex has secured additional capital. Although a spokesperson has confirmed that the new funding will assist Orbex in accelerating the development of Prime, ensuring its readiness and scalability for the launch period, the specific launch window has not been announced yet.

Post Views: 20
Continue Reading

Trending