As the FDA’s deadline to approve PMTAs nears, industry experts look back on the submission process.Read More
The PMTA process has had some errors and challenges as the FDA’s decision deadline looms.Read More
Scientific review is the final step in the PMTA process prior to FDA's decision to grant a marketing order.Read More
Broughton's Paul Hardman explores common causes and offers suggestions on how to prepare for them.Read More
The letter notified the company that the majority of their PMTAs did not meet the filing requirements.Read More
The FDA states that the company, Visible Vapors, did not submit PMTAs by the Sept. 9, 2020 deadline.Read More
Several issues are coming to light with the FDA's PMTA process, including falsely issued warning letters.Read More
The coalition letter, organized by the Americans for Tax Reform, wants an extension on the Sept. 9, 2022 deadline.Read More
BRS is offering any company that submitted a PMTA to the FDA a free gap analysis of their submission.Read More
The agency would like the FDA to ask the judge to suspend enforcement of PMTA rules for another year.Read More
