FDA on TEA confidentiality
This article was originally published in The Rose Sheet
Executive Summary
Agency will not keep confidential information that is necessary to meet the "material time" and "material extent" requirements of a Time and Extent Application, FDA says in letters to Merck KgaA, BASF and Symrise regarding the firms' respective requests to include enzacamene, octyl triazone and amiloxate in the OTC sunscreen monograph. For example, while FDA agrees to omit some information from each submission prior to putting it on public display, the agency tells BASF that information regarding specific sales, use and pricing data for select countries will not be redacted. The letters respond to specific requests made by each of the companies. FDA released its evaluation of the three TEAs earlier this year (1"The Rose Sheet" July 28, 2003, p. 11). The ingredients are among the first to be announced as eligible for monograph inclusion via the TEA process...
You may also be interested in...
Octyl Triazone Sales Of 400 Mil. Sunscreen Units Abroad Cited By FDA
Based on bulk material sales, nearly 400 mil. sunscreen dosage units containing octyl triazone have been sold in 35 countries, FDA notes in an evaluation of BASF's time and extent application for including the ingredient in the OTC sunscreen monograph
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
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.