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Regenerative Medicine
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It’s a drug think platinum are using drugs ?
A group purchasing organization (GPO) is a collection of companies that work together to improve the shared purchases of its members. GPOs can help members reduce costs by negotiating better deals on goods and services.
Big surprise thieves and liars act like themselves
Done be jealous that beeben russell is such a success story
My thoughts are with the numerous families impacted by this tragic situation, and my heart goes out to them.
I’m sure they are saving money for the lawyers or they will sell cars if the Federal Agency Personnel don’t seize over the Medicare injectable fraud
Wow so crazy that this is going on! Platinum Biologics seems like a criminal enterprise
Beeben Russel and Scott Martin and Marcus russell a.k.a. platinum biologics the Group purchasing organization are good guys get off them you must be jealous you don’t sell as much or can’t catch them. Kimera or vitti labs or who ever you are.
Re Platinum Biologics, Beeben Russell, Scott Martin M.D.
https://www.courthousenews.com/fda-...-magic-stem-cell-treatments-to-ninth-circuit/
PASADENA, Calif. (CN) — The U.S. Food and Drug Administration told a Ninth Circuit panel on Wednesday it has the authority to regulate a California provider of stem cell treatments that has been likened to "liquid magic."
The FDA is appealing the decision by a federal judge who concluded that the California Stem Cell Treatment Center's procedure, which involves extracting body fat from a patient, isolating stomal vascular fraction, or SVF, cells from the tissue and injecting these back into the patient, doesn't amount to creating a drug and falls under the so-called same surgical procedure exemption to FDA oversight.
The agency sued the Southern California clinic together with a Florida-based one in 2018, claiming they were disregarding patients' safety by peddling "unproven products that exploit the hope of patients and their loved ones."
But while the FDA won an injunction against the Florida clinic that was upheldby the 11th Circuit, the California case went to trial before U.S. District Judge Jesus Bernal in Riverside, who sided with the defendants. The Ninth Circuit decision on the FDA's appeal therefore could create a circuit split that might get the U.S. Supreme Court's attention.
Adam Jed, a U.S. Justice Department attorney representing the FDA, urged the appellate panel in Pasadena to follow the 11th Circuit's lead and find that the surgical procedure exemption doesn't apply to the stem cell treatment at issue. He contrasted the clinic's processing of the extracted fat with skin grafting, which he said is the classic application of the same surgical procedure exemption, where no one would dispute its the same piece of skin before and after.
"If you remove skin, you might wash blood off of it, you might trim the skin, but then you would return what anyone would say was skin," Jed said. "If instead you removed the skin and dissolved it in a vat of acid, and you skimmed off some portion of that slurry, and then you centrifuged off that slurry, and then you returned that, it would be very unnatural" to say the resulting combination of cells and debris was the removed skin.
In contrast to the lower court's conclusion that what was removed and returned were unaltered cells, Jed argued the clinic's process was "turning one thing into another."
Nathaniel Garrett, an attorney for the California Stem Cell Treatment Center, argued in response that the FDA was trying to rewrite the same surgical procedure exemption to get around the uncontested fact that the cells that are injected into the patients are the same as those that were removed, minus any superfluous tissue.
Focusing on the regulatory language, Garrett told the panel that the same surgical procedure exemption applies to clinics that remove human cells, tissues, and cellular and tissue-based products, or HCT/Ps, from an individual and implants such HCT/P’s into the same individual during the same procedure.
According to Garrett, the FDA is now trying to smuggle in processing and handling restrictions on the same surgical procedure exemption that weren't part of it when the rule was formulated 25 years ago.
"When they do care about processing and handling, they put it in the regulation," Garrett said. But when the FDA enacted the exemption for same surgery procedures, they said "processing controls are not going to apply. We are not going to impose processing limitations on the SSP exemption."
Clinics offering newfangled and unapproved stem cell therapies have sprung up all over the country in recent years, promising treatment for a host of chronic diseases and ailments, from multiple sclerosis and Parkinson’s disease to dementia and erectile dysfunction.
Stem cells have the ability to self-renew and to regenerate specialized cells in tissues. Given these unique regenerative abilities, they have been used as therapies to generate tissues but only a limited number of medical conditions can be safely and effectively treated with stem cell therapies, according to an amicus curiae brief filed by the International Society for Stem Cell Research and the International Society for Cell and Gene Therapy in the Ninth Circuit case.
One such treatment is the transplantation of blood-forming stem cells derived from bone marrow or umbilical cord blood for the reconstitution of the blood-forming and immune systems after chemotherapy or systemic radiation therapy.
"Unproven stem cell therapies marketed directly to consumers by clinics have resulted in patients being blinded, paralyzed, and infected with dangerous pathogens," the two organizations said in support of the FDA's appeal. "A lack of FDA oversight, caused by reduced federal regulation or by companies that evade FDA regulation, undermines adverse event reporting requirements and makes it harder to identify unapproved stem cell therapies that cause serious illness in patients."
The three-judge panel included U.S. Circuit Judges Kim McLane Wardlaw, a Bill Clinton appointee, Michelle Friedland, a Barack Obama appointee, and Jennifer Sung, a Joe Biden appointee. They did not indicate how or when they would rule.
https://www.courthousenews.com/fda-...-magic-stem-cell-treatments-to-ninth-circuit/
PASADENA, Calif. (CN) — The U.S. Food and Drug Administration told a Ninth Circuit panel on Wednesday it has the authority to regulate a California provider of stem cell treatments that has been likened to "liquid magic."
The FDA is appealing the decision by a federal judge who concluded that the California Stem Cell Treatment Center's procedure, which involves extracting body fat from a patient, isolating stomal vascular fraction, or SVF, cells from the tissue and injecting these back into the patient, doesn't amount to creating a drug and falls under the so-called same surgical procedure exemption to FDA oversight.
The agency sued the Southern California clinic together with a Florida-based one in 2018, claiming they were disregarding patients' safety by peddling "unproven products that exploit the hope of patients and their loved ones."
But while the FDA won an injunction against the Florida clinic that was upheldby the 11th Circuit, the California case went to trial before U.S. District Judge Jesus Bernal in Riverside, who sided with the defendants. The Ninth Circuit decision on the FDA's appeal therefore could create a circuit split that might get the U.S. Supreme Court's attention.
Adam Jed, a U.S. Justice Department attorney representing the FDA, urged the appellate panel in Pasadena to follow the 11th Circuit's lead and find that the surgical procedure exemption doesn't apply to the stem cell treatment at issue. He contrasted the clinic's processing of the extracted fat with skin grafting, which he said is the classic application of the same surgical procedure exemption, where no one would dispute its the same piece of skin before and after.
"If you remove skin, you might wash blood off of it, you might trim the skin, but then you would return what anyone would say was skin," Jed said. "If instead you removed the skin and dissolved it in a vat of acid, and you skimmed off some portion of that slurry, and then you centrifuged off that slurry, and then you returned that, it would be very unnatural" to say the resulting combination of cells and debris was the removed skin.
In contrast to the lower court's conclusion that what was removed and returned were unaltered cells, Jed argued the clinic's process was "turning one thing into another."
Nathaniel Garrett, an attorney for the California Stem Cell Treatment Center, argued in response that the FDA was trying to rewrite the same surgical procedure exemption to get around the uncontested fact that the cells that are injected into the patients are the same as those that were removed, minus any superfluous tissue.
Focusing on the regulatory language, Garrett told the panel that the same surgical procedure exemption applies to clinics that remove human cells, tissues, and cellular and tissue-based products, or HCT/Ps, from an individual and implants such HCT/P’s into the same individual during the same procedure.
According to Garrett, the FDA is now trying to smuggle in processing and handling restrictions on the same surgical procedure exemption that weren't part of it when the rule was formulated 25 years ago.
"When they do care about processing and handling, they put it in the regulation," Garrett said. But when the FDA enacted the exemption for same surgery procedures, they said "processing controls are not going to apply. We are not going to impose processing limitations on the SSP exemption."
Clinics offering newfangled and unapproved stem cell therapies have sprung up all over the country in recent years, promising treatment for a host of chronic diseases and ailments, from multiple sclerosis and Parkinson’s disease to dementia and erectile dysfunction.
Stem cells have the ability to self-renew and to regenerate specialized cells in tissues. Given these unique regenerative abilities, they have been used as therapies to generate tissues but only a limited number of medical conditions can be safely and effectively treated with stem cell therapies, according to an amicus curiae brief filed by the International Society for Stem Cell Research and the International Society for Cell and Gene Therapy in the Ninth Circuit case.
One such treatment is the transplantation of blood-forming stem cells derived from bone marrow or umbilical cord blood for the reconstitution of the blood-forming and immune systems after chemotherapy or systemic radiation therapy.
"Unproven stem cell therapies marketed directly to consumers by clinics have resulted in patients being blinded, paralyzed, and infected with dangerous pathogens," the two organizations said in support of the FDA's appeal. "A lack of FDA oversight, caused by reduced federal regulation or by companies that evade FDA regulation, undermines adverse event reporting requirements and makes it harder to identify unapproved stem cell therapies that cause serious illness in patients."
The three-judge panel included U.S. Circuit Judges Kim McLane Wardlaw, a Bill Clinton appointee, Michelle Friedland, a Barack Obama appointee, and Jennifer Sung, a Joe Biden appointee. They did not indicate how or when they would rule.
Navigating the Regulatory Framework for Regenerative Medicine: A Comprehensive GuideRegenerative medicine, a cutting-edge field that holds immense promise for revolutionizing healthcare, is subject to a complex regulatory landscape aimed at ensuring safety, efficacy, and ethical standards. Understanding the regulatory framework governing regenerative medicine is crucial for researchers, clinicians, and industry stakeholders. Let's delve into the key aspects of this regulatory framework:
- FDA Oversight: In the United States, the Food and Drug Administration (FDA) plays a central role in regulating regenerative medicine products. These products include cell therapies, gene therapies, tissue-engineered products, and combination products. The FDA evaluates these products based on safety, efficacy, and quality standards.
- Regulatory Pathways: Regenerative medicine products can be classified under different regulatory pathways based on their risk profile. These pathways include the traditional approval pathway, accelerated approval pathway, breakthrough therapy designation, and regenerative medicine advanced therapy (RMAT) designation.
- Good Manufacturing Practices (GMP): Manufacturing regenerative medicine products must adhere to strict GMP guidelines to ensure quality, consistency, and safety. Compliance with GMP regulations is essential for obtaining regulatory approval.
- Clinical Trials: Before a regenerative medicine product can be approved for market authorization, it must undergo rigorous clinical trials to demonstrate safety and efficacy. These trials are designed to gather data on the product's performance and potential risks.
- Ethical Considerations: Ethical standards play a crucial role in the regulation of regenerative medicine. Issues such as informed consent, patient privacy, and data protection are carefully monitored to safeguard patient rights and ensure ethical conduct.
- International Harmonization: Regenerative medicine regulations are not limited to the U.S. Many countries have their own regulatory frameworks governing these products. Efforts are being made to harmonize regulations globally to facilitate international collaboration and streamline market access.
- Emerging Trends: As regenerative medicine continues to advance rapidly, regulatory frameworks are evolving to keep pace with innovation. Regulatory agencies are adapting to new technologies and scientific developments to foster innovation while maintaining safety and efficacy standards.
Ha ha beeben Russel a.k.a. beeben russell a.k.a. platinum biologics. Saw your video what a hoot. anways regarding a Drug Master File or DMF The FDA keeps Drug Master Files (DMFs) confidential to protect proprietary information submitted by pharmaceutical companies. This allows companies to share details about their manufacturing processes, ingredients, and facilities without disclosing sensitive information to the public. Confidentiality helps encourage companies to provide necessary information for regulatory review without fear of competitive disadvantages or unauthorized use of their proprietary data. This is why you can’t find anything. A simple google would have helped you.
a bit more googling would have found you this.
Drug Master Files (DMFs) submitted to the FDA cover various aspects of pharmaceuticals, including:
1. **Chemical DMFs:** Provide detailed information about the chemistry, manufacturing, and controls of the drug substance.
2. **Biologic DMFs:** Contain information on the production, characterization, and testing of biologic products.
3. **Device DMFs:** Focus on details related to the manufacturing and design of medical devices.
4. **Packaging Material DMFs:** Include information about materials used in drug packaging.
5. **Drug-Device Combination DMFs:** For products that involve both a drug and a medical device.
6. **Excipient DMFs:** Contain information on the inactive ingredients used in drug products.
7. **Drug Substance Intermediate DMFs:** Cover details about intermediate steps in the drug manufacturing process.
Each type of DMF serves a specific purpose, allowing companies to provide the FDA with necessary information while maintaining confidentiality for proprietary aspects of their products.
so before you post false Information to slam others you should do a little more actual fact checking my man. 
a bit more googling would have found you this.
Drug Master Files (DMFs) submitted to the FDA cover various aspects of pharmaceuticals, including:
1. **Chemical DMFs:** Provide detailed information about the chemistry, manufacturing, and controls of the drug substance.
2. **Biologic DMFs:** Contain information on the production, characterization, and testing of biologic products.
3. **Device DMFs:** Focus on details related to the manufacturing and design of medical devices.
4. **Packaging Material DMFs:** Include information about materials used in drug packaging.
5. **Drug-Device Combination DMFs:** For products that involve both a drug and a medical device.
6. **Excipient DMFs:** Contain information on the inactive ingredients used in drug products.
7. **Drug Substance Intermediate DMFs:** Cover details about intermediate steps in the drug manufacturing process.
Each type of DMF serves a specific purpose, allowing companies to provide the FDA with necessary information while maintaining confidentiality for proprietary aspects of their products.
so before you post false Information to slam others you should do a little more actual fact checking my man.
Dear platinum biologics ,
The regulatory status of regenerative medicine products for cosmetic purposes can vary, and it's important to consider the specific details of the product and its intended use. A 361 product refers to a product regulated under Section 361 of the Public Health Service Act, which includes certain human cells, tissues, and cellular and tissue-based products (HCT/Ps).
If a product is being marketed for cosmetic purposes and involves intravenous therapy, direct injection, or nebulization, it may raise concerns about compliance with FDA regulations. The FDA regulates such products to ensure safety and efficacy.
For precise information on the legality of a specific product, it is recommended to consult directly with the FDA or seek legal advice from professionals with expertise in FDA regulations for regenerative medicine and cosmetic products.
The regulatory status of regenerative medicine products for cosmetic purposes can vary, and it's important to consider the specific details of the product and its intended use. A 361 product refers to a product regulated under Section 361 of the Public Health Service Act, which includes certain human cells, tissues, and cellular and tissue-based products (HCT/Ps).
If a product is being marketed for cosmetic purposes and involves intravenous therapy, direct injection, or nebulization, it may raise concerns about compliance with FDA regulations. The FDA regulates such products to ensure safety and efficacy.
For precise information on the legality of a specific product, it is recommended to consult directly with the FDA or seek legal advice from professionals with expertise in FDA regulations for regenerative medicine and cosmetic products.
one must read and understand. Ignorance is not acceptable
All easily found on Google yes now he is no longer at Home and garden shows or on Medicare town halls simply he beeben russell and Marcus russell are selling others products under there label form Texas via a executive suite on Flordia