FDA Pregnancy Registry Guidance Should Stratify Drugs By Prevalence Of Use
This article was originally published in The Tan Sheet
Stratification of drugs according to prevalence of use in women of childbearing age would assist industry in determining when pregnancy registries should be established, FDA's Reproductive Health Drugs Advisory Committee agreed at a meeting Oct. 18.
You may also be interested in...
Manufacturers will need to balance the "active recruitment" strategies for pregnancy registries urged by FDA with the agency's warning that recruitment efforts must not promote use in pregnant women, a draft guidance on pregnancy registries states.
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
Perrigo promotes in pricing, planning