FDA's health messages regulation
Reportedly, FDA has forwarded the final regulation to the Office of Management and Budget for approval. Agency proposed the rule to expand the allowable health claims for food products in August 1987 ("The Pink Sheet" Aug. 10, 1987, p. 6). Therapeutic, drug-like claims were excluded from the proposed rule.
You may also be interested in...
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.