The following is a little background information f
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Posted On: 09/15/2018 2:07:01 PM
The following is a little background information for those uncertain about the role of various government agencies. The Farm Bill has designated the FDA as the primary enforcement agency, and now other agencies must also begin changing their regulations.
FDA’s Role in the Drug Approval Process
The FDA has not approved marijuana as a safe and effective drug for any indication. The agency has, however, approved one specific drug product that contains the purified substance cannabidiol, one of more than 80 active chemicals in marijuana, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. The FDA has also approved two drugs containing a synthetic version of a substance that is present in the marijuana plant and one other drug containing a synthetic substance that acts similarly to compounds from marijuana but is not present in marijuana. The FDA is aware that there is considerable interest in the use of marijuana to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders.
Before conducting testing in humans of a drug that has not been approved by the FDA, an investigator submits an investigational new drug (IND) application, which is reviewed by the FDA. An IND includes protocols describing proposed studies, the qualifications of the investigators who will conduct the clinical studies, and assurances of informed consent and protection of the rights, safety, and welfare of the human subjects. The FDA reviews the IND to ensure that the proposed studies, generally referred to as clinical trials, do not place human subjects at unreasonable risk of harm. The FDA also verifies that there are adequate assurances of informed consent and human subject protection.
The FDA’s role in the regulation of drugs, including marijuana and marijuana-derived products, also includes review of applications to market drugs to determine whether proposed drug products are safe and effective for their intended indications. The FDA’s drug approval process requires that clinical trials be designed and conducted in a way that provide the agency with the necessary scientific data upon which the FDA can make its approval decisions. Without this review, the FDA cannot determine whether a drug product is safe and effective. It also cannot ensure that a drug product meets appropriate quality standards. For certain drugs that have not been approved by the FDA, such as marijuana, the lack of FDA approval and oversight means that the purity and potency of the drug may vary considerably.
As with other drugs that are not approved by the FDA, the agency works closely with the medical and patient communities, and our federal partners when necessary, to allow access to experimental treatments through the expanded access provisions described in the FDA’s statute and regulations. The FDA’s expanded access provisions are designed to facilitate the availability of investigational products to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy available, either because the patients have exhausted treatment with or are intolerant of approved therapies, or when the patients are not eligible for an ongoing clinical trial.
FDA Supports Sound Scientific Research
The FDA also has an important role to play in supporting scientific research into the medical uses of marijuana and its constituents in scientifically valid investigations as part of the agency’s drug review and approval process. As a part of this role, the FDA supports those in the medical research community who intend to study marijuana.
The FDA also supports research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research. Conducting clinical research using marijuana involves interactions with other federal agencies:
The Drug Enforcement Administration (DEA) reviews the registration application filed by the researcher.
The National Institute on Drug Abuse (NIDA) within the National Institutes of Health provides research-grade marijuana for scientific study. The agency is responsible for overseeing the cultivation of marijuana for medical research and has contracted with the University of Mississippi to grow marijuana for research at a secure facility. Marijuana of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute marijuana for research purposes.
https://www.fda.gov/NewsEvents/PublicHealthFo...421163.htm
Like I posted previously, the legalization process is complicated, and all these regulatory agencies are intertwined in the process. They have already made a major step forward by designating the FDA as the lead agency. Before the end of the month, the DEA will reschedule some elements of marijuana. However, I suspect only CBD will be rescheduled because the DEA still feels THC is mentally or psychologically addictive. A change of thinking at the DEA will likely require an act of Congress. That said, CBD is what we are looking for regarding UNVC/AGRiMED/SATIVEO because this is the substance with medical benefits and it is not a psychoactive substance. Good News for us, but bad for other companies that specialize in THC.
FDA’s Role in the Drug Approval Process
The FDA has not approved marijuana as a safe and effective drug for any indication. The agency has, however, approved one specific drug product that contains the purified substance cannabidiol, one of more than 80 active chemicals in marijuana, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. The FDA has also approved two drugs containing a synthetic version of a substance that is present in the marijuana plant and one other drug containing a synthetic substance that acts similarly to compounds from marijuana but is not present in marijuana. The FDA is aware that there is considerable interest in the use of marijuana to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders.
Before conducting testing in humans of a drug that has not been approved by the FDA, an investigator submits an investigational new drug (IND) application, which is reviewed by the FDA. An IND includes protocols describing proposed studies, the qualifications of the investigators who will conduct the clinical studies, and assurances of informed consent and protection of the rights, safety, and welfare of the human subjects. The FDA reviews the IND to ensure that the proposed studies, generally referred to as clinical trials, do not place human subjects at unreasonable risk of harm. The FDA also verifies that there are adequate assurances of informed consent and human subject protection.
The FDA’s role in the regulation of drugs, including marijuana and marijuana-derived products, also includes review of applications to market drugs to determine whether proposed drug products are safe and effective for their intended indications. The FDA’s drug approval process requires that clinical trials be designed and conducted in a way that provide the agency with the necessary scientific data upon which the FDA can make its approval decisions. Without this review, the FDA cannot determine whether a drug product is safe and effective. It also cannot ensure that a drug product meets appropriate quality standards. For certain drugs that have not been approved by the FDA, such as marijuana, the lack of FDA approval and oversight means that the purity and potency of the drug may vary considerably.
As with other drugs that are not approved by the FDA, the agency works closely with the medical and patient communities, and our federal partners when necessary, to allow access to experimental treatments through the expanded access provisions described in the FDA’s statute and regulations. The FDA’s expanded access provisions are designed to facilitate the availability of investigational products to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy available, either because the patients have exhausted treatment with or are intolerant of approved therapies, or when the patients are not eligible for an ongoing clinical trial.
FDA Supports Sound Scientific Research
The FDA also has an important role to play in supporting scientific research into the medical uses of marijuana and its constituents in scientifically valid investigations as part of the agency’s drug review and approval process. As a part of this role, the FDA supports those in the medical research community who intend to study marijuana.
The FDA also supports research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research. Conducting clinical research using marijuana involves interactions with other federal agencies:
The Drug Enforcement Administration (DEA) reviews the registration application filed by the researcher.
The National Institute on Drug Abuse (NIDA) within the National Institutes of Health provides research-grade marijuana for scientific study. The agency is responsible for overseeing the cultivation of marijuana for medical research and has contracted with the University of Mississippi to grow marijuana for research at a secure facility. Marijuana of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute marijuana for research purposes.
https://www.fda.gov/NewsEvents/PublicHealthFo...421163.htm
Like I posted previously, the legalization process is complicated, and all these regulatory agencies are intertwined in the process. They have already made a major step forward by designating the FDA as the lead agency. Before the end of the month, the DEA will reschedule some elements of marijuana. However, I suspect only CBD will be rescheduled because the DEA still feels THC is mentally or psychologically addictive. A change of thinking at the DEA will likely require an act of Congress. That said, CBD is what we are looking for regarding UNVC/AGRiMED/SATIVEO because this is the substance with medical benefits and it is not a psychoactive substance. Good News for us, but bad for other companies that specialize in THC.
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