The FDA is a governmental body that licenses and inspects legal drugs, additives and supplements. The DEA is a federal law enforcement agency dealing with drug crimes. From a federal standpoint it is felt that there is no acceptable medical use.
Many states do not take this position and have legalized medical cannabis. It is unknown if or when the federal government will legalize cannabis. If it is legalized, we have to ask ourselves if we want it to be controlled by the DEA. A strong benefit of FDA approval of cannabis as a pharmaceutical is the study of drugs under its supervision.
There are rigorous standards of safety and efficacy that have to be attained before FDA approval. This can prevent risking side effects. The cost of this is time. It can take years to achieve FDA approval. If cannabis is legalized and controlled by the DEA, I would expect that is would then become listed as a Schedule 2 drug. This MOU is intended to create a mechanism to facilitate timely sharing of information, and to build upon and establish additional collaborative efforts between the Federal Partners.
In an effort to achieve the goals described above, the undersigned agree to the following procedure for exchanging information:. Periodic Meetings: The Federal Partners will meet periodically for the purpose of discussing information exchanges between the Federal Partners. For the first year after the approval of this MOU, as described in section IX below, the meetings will be held quarterly, and thereafter on a biannual basis. Consistent with the waiver and amendment provision of this MOU in section VIII below, the frequency of these meetings may be increased or decreased.
The Authorized Officials shall be authorized to discuss and approve the procedures for information exchanges pursuant to this MOU, including the approval of Workplans, as discussed in section III. Each Federal Partner will provide a list of its Authorized Officials to the other Federal Partner and will update such list whenever Authorized Officials change. All Workplans must comply with applicable law as well as the terms and conditions of this MOU.
Once a Workplan is approved by an Authorized Official of Each Federal Partner, as documented by their signatures on the original Workplan, the Federal Partners may begin sharing information pursuant to that Workplan immediately. Persons Authorized to Exchange Information: Workplans will include the designation of one or more Authorized Contact Persons who will serve as primary points of contact for information exchanges between the Federal Partners.
The names of all Authorized Contact Persons, along with their contact information, must be identified in the Workplan or as an Addendum to it and the names and contact information must be kept up-to-date at all times. Timely Sharing of Information: Information exchanged pursuant to this MOU including under accepted Workplans will be exchanged in a timely manner, considering agency priorities and resources. Any instances of undue delay may be reported to an Authorized Official of each Federal Partner.
However, the undersigned acknowledge that each Federal Partner may be limited in its ability to share information or expertise in response to a particular request for several reasons, for example: agency priorities, resources, and statutory or regulatory prohibitions.
Methods of Sharing Information: The Federal Partners may share information in the following ways: in writing including in electronic form and e-mail and verbally whether in in-person meetings or by telephone, video-conferencing or other electronic means. When an Authorized Contact Person requests information, documents, or data in written form, the request should be made in writing, which may include an informal email. The following language should be included in the request:.
We agree not to further disclose any shared information in any manner without your written permission or, if such disclosure is required by law, without advance notice to the originating agency. With the inclusion of this statement, requestors would not have to use a particular format or include other pre-specified text. The response to such request should also be in writing, but it, too, can be an informal e-mail that acknowledges transmission of information in response to the request.
The following language should be included in the response:. The shared information may not be further disclosed in any manner without our express written consent or, if such disclosure is required by law, without advance notice to the originating agency. With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text. The Federal Partners may exchange information at meetings of the Federal Partners whether in person or by telephone, videoconference or other electronic means.
Approved Workplans will address such situations. Meeting notices, announcements, and any agendas for such meetings will include the following language:. Such information may not be further disclosed or shared in any manner without the express written consent of the originating agency or, if such disclosure is required by law, without advance notice to the originating agency.
Any verbal exchanges of the Federal Partners made pursuant to the MOU will be prefaced by the language above. Tracking of Information Exchanges: The Federal Partners will allow for tracking of information exchanges between them. The Dept. I looked up the difference using the FDA package inserts of the drugs and the phamacokinetics of the SA and ER and they are the same for verapamil. SA-ER for this drug. There is a verapamil PM or HS that is a hour delayed release which is different.
According to several sources, they are essentially the same thing. They both have an antihistamine, decongestant and cough suppressant. The manufacturers of C-Phen recently received an injunction letter from the FDA to permanently cease production of this product.
By definition, aspetic means free of pathogenic microorganisms. Whereas Sterile means absence of all the microorganisms. While the difference is clear, both terms are sometimes used interchangably. For example, FDA has a guideline on processing the sterile drugs in the Aspetic environment. But this guideline does not draw a clear distinction between the two categories. He is his mothers auntry's uncles sisters boyfriends brothers friend :. Is macadam FDA approved. Fda is food and drug adminastration.
Methamphetamine is a DEA Schedule 2 drug, meaning that it has an FDA medically approved use, but has a high potential for abuse and dependence. It is legal only if used in the appropriate medical setting and for the indicated medical condition, otherwise it is illegal to use.
If being sold as a food, no FDA approval needed. But it will be subject to FDA rules and regulations. Log in. Study now. See Answer. Best Answer.
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