On February 21, the Natural Product Association (NPA) filed a citizen petition with the Food and Drug Administration (FDA) on specific cannabidiol (CBD) relief in which it requests enforcement discretion for the premarket approval of CBD products. In its petition, the NPA is asking the FDA to do one of three things: Determine that CBD

The post New Citizen Petition Filed by CBD Company appeared first on Harris Bricken Sliwoski LLP.

Singers, Zinoleesky and Mohbad have been apprehended by operatives of the National Drug Law Enforcement Agency (NDLEA) after a midnight ... Read More

The once go-to industry payment processor, Shopify, is now banning the sale of all products containing more than 0.3% THC through their platform. That includes alternative cannabinoids like Delta 8 and 10, THC-O, THCP, and so on.   According to a Shopify email that’s making the rounds, products containing more than 0.3% of any type […]

The post Shopify is Banning All THC Products From Being Sold on Their Platform appeared first on CBD Testers.

Ireland: People With Chronic Pain Want Access To Medical Cannabis

Advocates suffering from chronic pain have launched the 'What About Us' campaign outside Leinster House, the seat of the Irish parliament in Dublin.

The post Ireland: People With Chronic Pain Want Access To Medical Cannabis appeared first on The Fresh Toast.

Mushrooms are becoming the next big thing, and that means more questions being asked. Like how to grow them? And if they mix well with weed. And whether or not you can smoke magic mushrooms. So, let’s take a look at that question today, and go over the different ways that magic mushrooms can be […]

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Therefore, if you are within an age category that is plagued with side effects that cannabis can treat – then not making cannabis legal for this age group is illogical to say the least. Of course, this doesn’t mean that anyone within this age group would benefit from cannabis. Some people may have conflict with their current regimen of medicine – which is why it’s important that if you are within this age group, to consult your primary care physician about your plans to incorporate cannabis into your life.

Constitutional Court President Giuliano Amato said that the country would have found itself in a compromising situation if the bill had been approved. Italy is a party to several international bodies and is obligated to maintain specific laws. The measure's multi-drug scope would result in a direct violation of these international laws.

The post FDA Guidance on Substantial Equivalence: Categories and Decision-Making Flowchart appeared first on RegDesk.

The U.S. Food and Drug Administration (FDA)  published on February 23^rd, 2022, a rule proposal to overhaul medical device quality control regulation.  According to the FDA, the proposed rule change would “amend the device current good manufacturing practice requirements of the Quality System Regulation to align more closely with the international consensus standard for devices by converging with the quality management system requirements used by other jurisdictions.”

The proposed rule, titled Medical Devices; Quality System Regulation Amendments, would incorporate by reference International Organization for Standardization ISO 13485:2016, which is the international consensus standard for medical device manufacturers.   The FDA claims that finalizing the proposed rule “will continue our efforts to align our regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.”  The FDA is also proposing to amend other aspects of its regulations to more closely align with the Food, Drug, and Cosmetics Act, as well as clarify good manufacturing practice requirements for co-packed and single-entity combination products.

Since early 2018, the FDA has said it is considering how to harmonize its regulatory requirements for medical device quality systems contained in 21 CFR part 820 with ISO 13485:2016, amid the international standard’s three-year transition period. This proposal would become effective one year from the publication date of February 23^rd, 2022, and would result in the replacement of its current inspection approach for medical devices, the Quality System Inspection Technique (QSIT), with an inspection approach that will be consistent with the requirements of the Part 820 as finalized.

Beyond the harmonization with international standards, the FDA estimates that this rule change will save between $439 million to $533 million over the next 10 years.  At the same time, it is expected that the expenditure for all companies to get up to speed with the proposed rule change will total $7.6 million.

The FDA had announced last week a March 2, 2022 meeting of the Device Good Manufacturing Practice Advisory Committee to “discuss and make recommendations on the current good manufacturing practice requirements for medical devices . . . to align more closely with an international consensus standard for medical devices used by other regulatory authorities.”

The text of the proposed rule change can be found here.

The post FDA Proposes Changes to Medical Device Quality Regulations appeared first on Knobbe Medical.

Doug Fine is known for evangelizing goats and gardens to save the planet, as well as advocating for the power of hemp.

The post Higher Profile: Doug Fine, Hemp Farmer and Goat Herder appeared first on High Times.

The regulatory mishmash that currently exists in Germany is putting both patients and other projects on hold, if not in limbo.

The post Setbacks In Germany Due to Delays on Forward Reform appeared first on High Times.

It’s not uncommon for a drug to enjoy its time in the sun before being put on a back shelf for something else. But the complete removal of a drug is harder to do, since black markets find ways of continuing on. Such is the case with quaaludes, however, which all but disappeared, leaving only […]

The post Where’d They Go? How Quaaludes Disappeared and Is Ketamine Next? appeared first on CBD Testers.