Aurobindo Pharma USA Inc – 05/15/2024

Haverhill, MA — Hans Kissle is voluntarily recalling 66 units of Hans Kissle Red Potato Bliss Salad due to undeclared allergen (wheat). People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

As displayed in the Federal Register notice on August 1, 2018, FDA is conducting a Complex Innovative Designs (CID) Meeting Program to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs, as highlighted in the sixth iteration o

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.

Unapproved New Drugs/Misbranded

FDA issues draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.” The draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs.