FDA supplement ombudsman
This article was originally published in The Tan Sheet
Executive Summary
Rep. Frank Pallone (D-N.J.) urges HHS Secretary Tommy Thompson to establish a dietary supplement ombudsman position at FDA, in Feb. 21 letter. Pallone states ombudsman "would be responsible for providing guidance on many of the questions the industry and the public have with regard to dietary supplements. [He] would help address the need for centralized authority and accountability within FDA." American Herbal Products Association called for a supplement ombudsman at FDA in a 2001 letter to the White House Commission for Complementary & Alternative Medicine (1"The Tan Sheet" July 30, 2001, In Brief). Pallone's letter also calls for the release of GMPs, noting they have been delayed numerous times...
You may also be interested in...
WHCCAMP
FDA should initiate a review process much like its ongoing OTC monograph review to evaluate botanicals and appoint a "dietary supplement ombudsman," American Herbal Products Association asserts in recent letter to White House Commission for Complementary & Alternative Medicine. AHPA maintains agency's August 2000 "Botanicals Drug Guidance" does not sufficiently address marketing botanicals with a long history of use as nonprescription drugs. WHCCAMP also should recommend FDA employ "responsible advocate" for supplement industry in its report to President. Interim report was scheduled for July 16, but has yet to be released (1"The Tan Sheet" July 9, p. 8)
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.