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 COVID-19.
On March 30th the FDA had put in to have the PMTA submission deadline postponed until September 9, 2020. This was approved as of April 6th. So what does this mean for manufacturers
What to Expect from the Postponement
While it is true that manufacturers now have more time to submit. The entire reason that the date was postponed was for reason like laboratories not being open. So what’s the best thing you can do during this period? Well during this you could conduct your studies, right? That would be wrong too with COVID-19 being a respiratory illness many places have stopped clinical trials and studies to protect those at risk like smokers and vapers.
During this time the best thing you could do would be to prepare everything you can without the laboratories and outside studies. To get a better idea of what this could be or what needs to be done you can call us today for a free consultation!