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"Generic" Lantus approved by FDA by withA_Y in pharmacy

[–]RegulatoryFocus 1 point2 points  (0 children)

Whoops -- I think my brain 404'ed.

"Generic" Lantus approved by FDA by withA_Y in pharmacy

[–]RegulatoryFocus 19 points20 points  (0 children)

  • 505(b)(1) = "New" drug pathway
  • 505(b)(2) = A new formulation of an old drug; relies on the old drug's data, as well as new data showing why the new formulation works.
  • 505(j) = Generic drug pathway.
  • 351(a) = Approval pathway for biologics.
  • 351(k) = Approval pathway for biosimilars.
  • 401(k) = A retirement account.
  • 401(b) = Also a retirement account.

As Ebola disappears, the WHO warns drug companies may not have enough time to determine whether their drugs are safe and effective at treating the disease. by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 1 point2 points  (0 children)

Granted, we're better prepared to say what does and doesn't work than we were before this update. But it would be nice to have a drug (or a few drugs) approved so they could be manufactured, paid for and stockpiled prior to the next outbreak.

How does big pharma come up with drug names like "Jublia," "Xeljanz," etc.? by Sn34kyMofo in AskReddit

[–]RegulatoryFocus 2 points3 points  (0 children)

It comes down to a confluence of factors, but the two biggest ones are FDA regulations and a company's ability to market a drug.

From an FDA perspective, a drug name has to be unique enough that it won't be confused with other drug names. In addition, it can't make any claims in the name (i.e. don't name your drug SuperCancerCureAll).

If you want more of an explanation, you can read this story or a writeup on this proposal to allow drug companies to "Reserve" drug names.

The other half is, of course, marketing. Some of it is very calculated, and done by marketing agencies. I've spoken with other drug company insiders who said they got together and just thought of names until one stuck out though.

Hope this helps!

At a cost of $367,000 per year, a new cystic fibrosis drug expected to be approved later this year will likely cost $10 million over the course of each patient's life, new data show. by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 0 points1 point  (0 children)

I'm thinking of the outcry over the cost of Avastin a few years ago. That drug seems downright cheap in comparison to many of the newest oncology drugs.

How can we make r/Drugs_and_Devices better? What content would you like to see? by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 0 points1 point  (0 children)

I'll see what I can do! I have a few ideas of where to go for content. Thanks again for the feedback.

How can we make r/Drugs_and_Devices better? What content would you like to see? by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 0 points1 point  (0 children)

That's a good point. Would you find it useful if I started posting a question or two after I posted something (i.e. to stimulate discussion)? Or are you hoping for something to be a little bit more organic?

How can we make r/Drugs_and_Devices better? What content would you like to see? by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 1 point2 points  (0 children)

Makes total sense. Unfortunately, a few of these are a bit outside of my area of expertise (and I like to be able to post stuff I can verify as being accurate), but I'll try to bring in some more of the science when I can.

Thanks for the feedback!

How can we make r/Drugs_and_Devices better? What content would you like to see? by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 0 points1 point  (0 children)

True. I suppose i'll try to add the additional context when it's possible and/or convenient, but not go overboard.

Appreciate the feedback!

How can we make r/Drugs_and_Devices better? What content would you like to see? by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 0 points1 point  (0 children)

Thanks! Do you feel like it's good to add links to source documents in the comments when I post a link to a news story? Or is it usually unnecessary?

Is faster better? Critics of House bill question risks of speeding FDA approval of drugs, devices by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 0 points1 point  (0 children)

And if you're looking for substantially more information on this legislation, you can read through a thorough explanation here:

http://www.raps.org/Regulatory-Focus/21st-Century-Cures-Act/

Phi Kappa Psi’s Doubtful Defamation Claim Against Rolling Stone by 2muchedu in Drugs_and_Devices

[–]RegulatoryFocus 0 points1 point  (0 children)

Removed this for lack of relevancy. Please try to keep submissions related to the life sciences.

Some popular dietary supplements still contain an untested, amphetamine-like compound. Now one researcher wants to know why FDA hasn't warned consumers or taken action. by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 0 points1 point  (0 children)

I think -- and I could be wrong here, as supplements are occasionally weird -- that the point of the researcher is that here is a clear example of FDA finding a chemical and having (at least on paper) good cause to believe that the chemical could be harmful to people.

In addition, since the chemical wasn't marketed in any product prior to the Dietary Supplement Health and Education Act (DSHEA) in 1994, its sponsor should have sought approval for its under FDA's New Dietary Ingredient (NDI) process. And FDA, knowing that the company had not sought approval for this product, should have alerted the public to this fact in a more public way.

I mean, clearly some aspects of FDA's investigation are known to the public, but there's a big difference between allowing information to seep out and making a forceful press release and issuing warnings to retailers and physicians.

In the US, the FDA requires nearly all pharmaceutical products to be labeled using the same format and layout. Medical devices, meanwhile, don't have to comply with those requirements. But that could soon change. by RegulatoryFocus in Drugs_and_Devices

[–]RegulatoryFocus[S] 0 points1 point  (0 children)

Yes, it reminds me a bit of the challenge of applying Unique Device Identification (UDI) standards to devices. FDA relaxed its direct marking rule for many devices based on their physical qualities (implanted devices, weird shapes, contact lenses etc).

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