by monica | Oct 27, 2020 | Uncategorized
Today the FDA posted new potential guidance for the industry and it is now open for commenting beginning tomorrow. This new potential guidance gives a strong outline for Perception and Intention Studies. Per the FDA’s definition “TPPI studies are studies that can be...
by monica | Apr 7, 2020 | Uncategorized
Due to the global pandemic caused by COVID-19, manufacturers had written letters to the FDA urging them to push back the PMTA submission date. Especially considering that many manufacturers have locations in South America and China that have been severely affected by...
by monica | Mar 6, 2020 | Uncategorized
FDA Accepting Research via Forum The FDA is opening a comment forum for CBD in correlation to their May 2019 forum. This decision is made to help the FDA gather more information on CBD and its users. In addition to gaining a better understanding of the products on the...
by monica | Sep 19, 2019 | Uncategorized
Trump Administration Supports a Ban on Flavored Vape Products On September 11th, 2019, the Trump Administration announced that, after six deaths and 450 vape related illnesses, it intends to issue a finalized guidance in the coming weeks which will amend the FDA’s...
by monica | Jul 12, 2019 | FDA
Download Legislation Here Order-Re-RemedyDownload Court ruling of AAP V. FDA was released today regarding PMTA. Court Order: The FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule (“New...
by monica | Jul 9, 2019 | FDA
As third quarter is officially in full swing now is a great time to breathe and reflect on what actually happened in second quarter especially in June. The FDA as we all know was very busy in the month of June, but while PMTA has dominated the news in the industry;...
by monica | Jun 13, 2019 | FDA
The FDA has officially put out new guidance for the PMTA also known as Premarket Tobacco Product Applications. The official statement the FDA issued with the announcement of these new guidelines was “The FDA is committed to providing a solid, science-based regulatory...
by monica | Jun 1, 2019 | Uncategorized
In a sweeping new decision Vermont has passed legislation to ban the online sale of tobacco products. The exact legislation as it reads “Sec. 2. 7 V.S.A. § 1010(b) is amended to read: (b) No person shall cause cigarettes, roll-your-own tobacco, little cigars, or...
by monica | May 23, 2019 | FDA
As of May 23, 2019 the FDA is starting a new program “to give CTP staff an opportunity to visit facilities that develop, manufacture, or test ENDS devices or e-liquids… to gain a better understanding of the processes involved in the development, manufacturing,...
by monica | Feb 21, 2019 | Uncategorized
There is a difference between managing a business and being an entrepreneur. Truth be told, many entrepreneurs despise the minutiae of managing their business and prefer to focus on big ideas and innovation. While the characteristics of an entrepreneur come in a...
