DUBLIN, Oct. 24, 2019 -- (Healthcare Sales & Marketing Network) -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental Biologics License Application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to...
In addition, because the federal government considers all speech about an off-label use “false or misleading,” such speech misbrands a drug under section 502(a) of the FDC Act. WLF’s brief supplements Allergan’s complaint by expounding on two topics: (1) the importance of off-label ...
“The law doesn’t require cosmetic firms to register with FDA or to submit their products, ingredients, labeling or claims to FDA for approval before the products go on the market (with the exception of color additives, which must be approved by FDA),” an FDA spokesperson said by e-mail...