Category Archives: Drug Safety Information Podcasts

FDA awards 18 grants to stimulate product development for rare diseases

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.

FDA issues orders that will stop further U.S. sale and distribution of four R.J. Reynolds Tobacco Company cigarette products

Today the U.S. Food and Drug Administration issued orders that will stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products – including its Camel Crush Bold brand – because the company’s submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA approves new drug treatment for nausea and vomiting from chemotherapy

The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

FDA takes action against three tobacco manufacturers for making “additive-free” and/or “natural” claims on cigarette labeling

Today the U.S. Food and Drug Administration issued warning letters to three tobacco manufacturers — ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. — who describe their cigarettes on product labeling as “additive-free” and/or “natural.” The warning letters are for violations of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA extends use of Promacta in young children with rare blood disorder

The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen.