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The North American College of Pharmaceutical Technology (NACPT) is conducting a pilot series of professionals in medical cannabis workshops, and we spent a day learning and discussing food safety, regulatory tech, processes and systems. Is the temperature and humidity control right for product safety? Source: [link].
This bill mandated that the Division of Criminal Justice in the Department of Public Safety conduct a study of the impacts of Amendment 64, particularly as these relate to law enforcement activities. Furthermore, the measurement of available data elements can be affected by very context of marijuana legalization. 13-283 (C.R.S.
Law enforcement, policy makers, and public citizens have long debated how recreational marijuana legalization influences crime and public safety. Data tells us that more arrests for marijuana trafficking and possession occur after marijuana legalization in neighboring states, concentrated at the bordering counties.
Reporting to the Regulatory Affairs Manager, the RPS supports functions related to tracking regulatory information and document styling and publishing in eCTD format for regulatory submissions. Position duties: Electronic document preparation and submission of electronic common technical document (eCTD) submissions to regulatory agencies.
Despite the increased use of medical cannabinoids, the efficacy and safety of the treatment among children remain uncertain. The objective was to study the efficacy and safety of medical cannabinoids in children. Systematic review and meta-analysis were performed to examine the efficacy and safety of MCs treatment among children.
. … An association of marijuana testing labs is calling on the state to release unredacted data from Nevada’s seed-to-sale tracking system amid assertions that certain unidentified labs are inflating THC content readings and giving fewer samples a failing grade in an apparent attempt to attract more business. THE DOCUMENT.
The 14-page document covers several aspects of the drug development process, including trial best practices, data collection, and new drug application requirements. The document also addresses study participant safety emphasizing how psychedelics’ psychoactive effects increase the potential for abuse.
Research funding is also up, and all of this data influences how we see, think and hear about the plant and its effects. Additionally, there are misleading practices of “p-hacking” where researchers can manipulate data through different statistical tests (thanks to modern computer programs) looking for statistically significant findings.
Producers must document the destruction or disposal of all noncompliant hemp and provide corresponding documentation to the WSDA. If that happens, the entire lot must be destroyed. There is a caveat as a hemp producer may request a resampling or retesting within 30 days. Hemp as food.
The European Food Safety Authority (EFSA) has looked at THC levels in 12 different categories of hemp foods, including hemp oil, breads and teas. The January report from the European Food Safety Authority (EFSA) looked at THC levels in 12 different categories of hemp foods, including hemp oil, breads and teas. Davide Arcella . .
Hemp Roundtable (“the Roundtable”) appreciates the opportunity to provide comments to FDA in response to its request for scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. 2019.07.16-US-Hemp-Roundtable-FDA-Comments.
Whereas some might believe steps taken by governments and organizations to screen and/or prevent cannabis use are supported by empirical evidence, such commentary is often based on speculation, vested interests, and pseudo-science rather than on objective interpretation of all available scientific data.
The results of the clinical trial have been submitted in the Clinical/Statistical Report (“CSR”) filed with the FDA, and relevant data is also available on Form 8-K filed with the SEC on December 2, 2021. On the anxiety and depression scales, we documented a decrease of approximately 50% to 60% in patients who received the drug.
Enhanced Privacy and Discretion Digital platforms ensure privacy by securely managing patient data and facilitating confidential interactions between patients and healthcare professionals. Patients can submit required documents electronically, accelerating the review and approval process.
This comprehensive document includes both a general summary of current research on cannabis use and more specific findings on its role in cardiovascular health and health risks. Thirdly, the statement notes that there are currently no “well documented” cardiovascular benefits of cannabis. ACUTE EFFECTS OF MARIJUANA.
At the end of the programme, Evotec will provide the Company with a submission-ready regulatory document which will be used for submissions to regulatory agencies, as well as drug-batch approved and ready for First Time in Human clinical trials. Since the year-end, the £2.6
Mainly, the measure protects patient safety and amplifies product quality requirements, all the while entrusting the state’s Medical Marijuana Advisory Board to consider broadening the program’s list of qualifying medical conditions. Pennsylvania’s Medical Cannabis Program is Raking in the Cash.
Orr further wrote that the company has been working with the FDA for 18 months and has provided more than enough information about their “cultivation, extraction, manufacturing, use and safety” of their proprietary FSHE. . Regarding safety, the conclusions drawn by the FDA do not appear to be based on the data provided in our NDI application.”
The bill, Legislative Document 1195 , authorizes $20,000 reimbursements to help towns and cities pay for expenses associated with the state’s adult-use program roll-out, including legal fees, drafting or amending ordinances, conducting town meetings and holding elections.
Data were collected at three different time points: baseline, 4, and 8 weeks. Despite the documented adverse effects, opioids are widely used for pain management. Cannabinoids, and specifically Cannabidiol, is proposed as an opioid alternative, having comparable efficacy with better safety profile.
This “zero recall” standard, the team said, was attributed to the fact that their cannabis product standards with regard to food safety and health was high and involved documentation of over 100 pages. . triggering new innovations and improved data quality through better user experiences.
The new report also documents how Monroe County has one of the highest arrest rates for low-level marijuana-related offenses in New York State: Monroe ranks fifth-highest by county for low-level marijuana possession (outside of NYC).
The Association of Official Analytical Chemists (AOAC) publishes microbiological and chemical standards used globally to promote trade and to facilitate public health and safety. Some manufacturers are selling food safety testing methods to the cannabis market. Review the manufacturer’s validation data, and conduct your own validation.
CBD market comes shortly after the country’s Food and Drug Administration issued a statement last month that it cannot conclude the cannabis compound’s safety in human or animal food products. market, according to financial documents released last month. government agency said on its website. ” Canopy’s new U.S. .
The researchers stated that these knowledge gaps must be addressed and that “clinical trial data about how medical cannabis improves patient quality of life domains is desperately needed as this information can impact clinical decision-making.”.
The Program Specialist 2 (Cannabis) positions will perform applicant and licensee inspection of physical facilities, adherence to program regulations, development of guidance documents and statement of findings and other duties ensuring licensees are complying with public health and safety best practices.
Cannabis-based products will be allowed to bypass usual processes required for medicines in New Zealand and go directly onto the market without any proof of safety or effectiveness. This unprecedented proposal is contained in the government’s consultation document on giving greater access to medicinal cannabis.
Beyond Pesticides , October 8, 2019) As medicinal and recreational marijuana continue to be legalized in a growing number of states, concerns about the safety of the burgeoning industry—how the substance is grown, harvested, processed, distributed, sold, and used—have emerged. Congress should intervene to protect public health and safety.
Legal frameworks aim to ensure patient safety, privacy, and quality of care while adapting to technological advancements. Medical Documentation Submission: As part of the application process, patients are usually required to submit medical documentation supporting their condition. Encryption ensures patient data security.
Earlier this year, the FDA petitioned the industry to provide safety and efficacy data to the agency so that it may appropriately regulate products containing the increasingly popular ingredient cannabidiol, also known as CBD. UK is ranked among the top 30 campuses in the nation for LGBTQ* inclusion and safety. About ValidCare.
By placing the sequence of a Type II plant public, we can help enable the community to sequence their documented Pre-2013 Type II plants. They can then compare their sequence to this public reference to document the Bt:Bd allele (mentioned in some of the claims) and any other similarities. Note- this is unpolished data.
Manufacturers generate validation data to demonstrate their test can detect the target molecule/organism with high sensitivity and specificity. For our HLVd Validation Document , we mirrored the validation experiments we performed to meet the AOAC standards for our Microbial Safety Testing Assays ( Salmonella , E.
Several barriers to use were identified including discordant legal status between state and federal governments, concerns about clinical efficacy and safety, and a myriad of other societal factors. Wide variations in MC documentation and education practices between hospices were noted.
Ensure that going forward, CBD manufacturers would be able share safetydata through existing FDA notification procedures to be fully compliant with federal law and policy. Specifically, the language in the document. The US Hemp Roundtable writes. McConnell-Language.
Data & Software. Nearly every single state requires license holders to document compliance using seed-to-sale tracking software. This ensures that at any moment data can be sourced from every legal cannabis plant that has been grown and sold. Business data should be readily available and easily accessible at all times.
CLARA uses natural language processing to perform contextual analysis, incorporating structured, semi-structured and unstructured data into its AI analysis. The National Highway Traffic Safety Administration (NHTSA) reports that the percentage of fatally injured drivers who tested positive for drugs increased from 25% in 2007 to 42% in 2016.
The study was conducted by a respected contract research organization with deep expertise in preclinical oncology model development and drug testing and data corresponding to all studied cancer cell lines have now been reported to the Company. ” Next Steps.
Later, the former youth and sports minister took to Twitter to say he was really impressed by the health minister’s response to his question, commending the ministry’s data and science-driven decision-making process. The document was made available on the Parliament website today.
Flora Pharma will seek to identify scientific gaps in the cannabis industry and ultimately work to translate that to pharmaceutical cannabis products backed by data. Flora Pharma expects to fast track traditional FDA and NHS timelines by running phase trials in parallel (in vitro, in vivo, pilot in human, safety/efficacy, etc.).
This document reviews each state’s adult-use cannabis tax structure, population, and revenue from legalization. Data for tax revenue from wholesale taxes has not yet been made available. 19 Note : This estimate is calculated by applying the 17% tax to the cumulative sales data provided at this link: [link]. 1 [link].
The FDA published a Guidance Document in the Federal Register, outlining the topics regarding cannabis that they would like public comment on. It is refreshing when a Federal Agency demonstrates willingness to work with the hemp industry toward a common goal.
Interpret data to assess crop health and quality and adapt to growth conditions/pest management strategies. Develop and implement a costing system to accurately document and track crop production costs. Interpret data to assess crop health and quality and adapt to growth conditions/pest management strategies. And much more!
Many of the safety issues in the report involve the use of CBD without the guidance of a health care professional. This is mainly due to a lack of data. The agency originally published a document in June of this year, cautioning against marketing CBD as a dietary supplement.
A definition would be added for “source documentation” which means “an original document that contains the details of a marihuana business transaction.”. R 420.208 Building and fire safety. R 420.306 Testing marihuana product after failed initial safety testing and remediation. R 420.212 Storage of marihuana product.
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