Pregnancy claims
FDA will hold a public meeting March 30 on safety issues related to dietary supplement use during pregnancy. In a notice to be published in the Feb. 24 Federal Register, FDA seeks comments on five points: potential maternal and fetal hazards associated with supplement use for pregnancy-related conditions; existence of certain pregnancy-related conditions for which structure/function claims should be permitted; potential harm of using supplements during pregnancy for conditions unrelated to pregnancy; means of addressing safety concerns associated with supplement use during pregnancy; and use of specific warnings on supplements for pregnancy-related conditions. The meeting is 9 a.m. to 5 p.m. at the Hilton in Gaithersburg, Md.; comments are due within 60 days of the Federal Register notice date
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.