OTC review
This article was originally published in The Tan Sheet
Executive Summary
FDA issues call for data on antidiarrheal ingredient Saccharomyces boulardii 250 mg in capsule form taken one to two times daily, according to a notice slated for publication in the Federal Register Aug. 23. The agency "has reviewed a time and extent application for this condition and determined that it is eligible for consideration in its OTC drug monograph system." The notice adds that either an official or proposed U.S. Pharmacopoeia-National Formulary monograph must be submitted as part of the review because one was not included as part of the TEA...
You may also be interested in...
FDA withdraws monograph bid for diarrhea drug
FDA withdraws its 2004 notice of eligibility and request for information to aid its consideration of adding Saccharomyces boulardii to the antidiarrheal OTC drug product monograph. FDA determined the yeast is best regulated as a biological product, the agency said in an Oct. 27 notice in the Federal Register (1"The Tan Sheet" Aug. 23, 2004, In Brief)
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.