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Obama Signs The 21st Century Cures Act
- Thread starter Pray The Bald Away
- Start date
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- 214
I wish he didn't wait so long.
It just got to him.
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I don't know how this helps hair loss
I thought it was more about funding research for cancer and alzhiemers and serious life threatening illnesses and rushing medicines to patients who are really ill to be able to have experimental medications.
Covers everything?
I thought it was more about funding research for cancer and alzhiemers and serious life threatening illnesses and rushing medicines to patients who are really ill to be able to have experimental medications.
Covers everything?
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- 540
the article said this act can speed up approval process for new drugs and medical devices, so knock knock doesn't that mean something?
anyway the hair loss researchers can sue the lawsuits by this law for approval of their products.( LAW THINGS........)
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Knock knock==dont be a wise ***
Was it specifically for ALL medications for something like hair loss that is basically cosmetic?
Or for life threatening or disabling illnesses? like cancer and alzheimer
Do you know if its ALL medications?
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it says " INCLUDING CANCER AND ALZHEIMER" so there's a good chance other medications are also applicable.
I am not implying i am damn sure but the hair loss researchers can use this act for their benefit.
BTW i didn't mean KNOCK KNOCK==dont be a wise ***
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stems cells can also be used for cancer treatment in future
so they won't remove it from their list.
Noisette
Established Member
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- 1,341
An interesting article for this 21st century cures act
Source: http://www.bioinformant.com/21st-century-cures-act/
"
It is great progress that the U.S. is getting behind the development of innovative regenerative medicines, including cell therapy, with the passing of the 21st Century Cures Act.
The bill, passed by both houses of Congress and signed into law today by President Obama, puts the U.S. on the same playing field as many other developed countries including those in the European Union (EU) and Japan, which already have accelerated regulatory pathways for regenerative therapies. The initiative will support President Obama’s cancer “moonshot,” Alzheimer’s research, and efforts to address opioid addiction.
The bill encourages late-stage development in regenerative medicine, recognizing the field’s potential to address severe unmet medical needs. It also correctly identifies regenerative therapy as a category in its own right.
According to Yaron Ramati, Pluristem’s Regulatory Affairs Director, the proposed FDA oversight of this therapeutic field should ensure high standards for quality and safety, facilitate early patient access to therapies with proven efficacy, and address serious and life-threatening conditions. Pluristem Therapeutics is, to the best of my knowledge, the only company in the world to have a program selected for advanced regulatory pathways in both Europe and Japan, which is why their perspective on the 21st Century Cures Act is valuable.
the 21st Century Cure Act is a powerful step forward, and one that is largely supported by all but the most conservative within the scientific and medical communities. Those that oppose it are outnumbered and those that support it are realistic in assessing that it is a “step forward” and not panacea to all healthcare related concerns.
Positioning America as a Global Player in Regenerative Medicine
Perhaps the greatest significance of the bill is its ability to position the U.S. as a force for regenerative medicine, alongside Japan and the European Union (EU). In particular, Japan has accelerated its position as a hub for regenerative medicine research, largely driven by support from Prime Minister Shinzo Abe who has identified regenerative medicine and cellular therapy as key to the Japan’s strategy to drive economic growth. His strategic plan also authorizes approximately ¥110 ($1 billion) in funding for stem cell research within Japan.
Japan’s Accelerated Pathway for Regenerative Medicine took effect on November 2014, under which regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and initial proof of efficacy. Safety and effectiveness then needs to be confirmed within seven years of conditional approval. The importance of this law is that it allows companies a quicker, more efficient path to commercialization ".
Source: http://www.bioinformant.com/21st-century-cures-act/
"
It is great progress that the U.S. is getting behind the development of innovative regenerative medicines, including cell therapy, with the passing of the 21st Century Cures Act.
The bill, passed by both houses of Congress and signed into law today by President Obama, puts the U.S. on the same playing field as many other developed countries including those in the European Union (EU) and Japan, which already have accelerated regulatory pathways for regenerative therapies. The initiative will support President Obama’s cancer “moonshot,” Alzheimer’s research, and efforts to address opioid addiction.
The bill encourages late-stage development in regenerative medicine, recognizing the field’s potential to address severe unmet medical needs. It also correctly identifies regenerative therapy as a category in its own right.
According to Yaron Ramati, Pluristem’s Regulatory Affairs Director, the proposed FDA oversight of this therapeutic field should ensure high standards for quality and safety, facilitate early patient access to therapies with proven efficacy, and address serious and life-threatening conditions. Pluristem Therapeutics is, to the best of my knowledge, the only company in the world to have a program selected for advanced regulatory pathways in both Europe and Japan, which is why their perspective on the 21st Century Cures Act is valuable.
the 21st Century Cure Act is a powerful step forward, and one that is largely supported by all but the most conservative within the scientific and medical communities. Those that oppose it are outnumbered and those that support it are realistic in assessing that it is a “step forward” and not panacea to all healthcare related concerns.
Positioning America as a Global Player in Regenerative Medicine
Perhaps the greatest significance of the bill is its ability to position the U.S. as a force for regenerative medicine, alongside Japan and the European Union (EU). In particular, Japan has accelerated its position as a hub for regenerative medicine research, largely driven by support from Prime Minister Shinzo Abe who has identified regenerative medicine and cellular therapy as key to the Japan’s strategy to drive economic growth. His strategic plan also authorizes approximately ¥110 ($1 billion) in funding for stem cell research within Japan.
Japan’s Accelerated Pathway for Regenerative Medicine took effect on November 2014, under which regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and initial proof of efficacy. Safety and effectiveness then needs to be confirmed within seven years of conditional approval. The importance of this law is that it allows companies a quicker, more efficient path to commercialization ".
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I think you're right. I think I read somewhere that the criteria for early approval is not necessarily that the treatment treats a life-threatening illness. Rather, I think I read that the treatment has to be for an illness (or health condition) where there's an unmet need. And it's my recollection that when I read that article the term "unmet need" was defined as a situation where currently available treatment(s) do not exist or do not work well.
Now don't quote me on this because I read this last year after the house of reps first agreed to the law. The law could have changed since then.
I found an article confirming my point about getting treatments to market quicker if there's an unmet need and it looks like this provision is inside of the final version of the bill because this article is very recent.
https://www.statnews.com/2016/12/01/21st-century-cures-act-fda-approval/
https://www.statnews.com/2016/12/01/21st-century-cures-act-fda-approval/