FDA Ushers Out Known DMAA, Closes Dietary Ingredient Door
USPlabs says it will reformulate its DMAA supplements, although it “stands by the safety and legality” of the products. FDA says “credible science” shows DMAA is not a botanical, not a dietary ingredient and will not be accepted in an NDI notification.
Learn what's happening at the US FDA. On the go.
More from Latin America
Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.
Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines.
More from Geography
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.