Infant formula GMPs
This article was originally published in The Tan Sheet
Executive Summary
FDA is extending the comment period on its proposed infant formula GMPs and quality control procedures for 60 days to Aug. 26, agency announces in 1June 27 Federal Register notice. Action follows request from International Formula Council citing need for more time to prepare comments (2"The Tan Sheet" May 26, 2003, In Brief)...
You may also be interested in...
Infant formula GMPs
Comment period on proposed infant formula GMPs and quality control procedures should be extended 60 days to Aug. 26, International Formula Council says in May 6 comments to FDA. Group is requesting extension "on behalf of all U.S. manufacturers of infant formula," noting "appropriateness of granting this extension is further underscored by the fact that only a few responders...are affected directly and their comments are anticipated to be comprehensive and in-depth and to require significant preparation time." FDA reopened comment period on the proposed rule, which was issued in 1996, in April (1"The Tan Sheet" May 5, 2003, In Brief)...
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.