The letter notified the company that the majority of their PMTAs did not meet the filing requirements.Read More
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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
The company submitted PMTAs for 992 SKUs of its Jvapes e-liquids before the FDA's Sept. 9, 2020 deadline.Read More
The new language clarifies the intended purpose of deficiency letters is only to communicate information gaps.Read More
Companies that received the latest round of letters have a combined 750 products registered with the FDA.Read More
The regulatory agency issued two more warning letters for companies selling e-liquids without having filed a PMTA.Read More
The meeting will feature a presentation from CTP Office of Science Director Matt Holman. Read More
