FDA In Brief: FDA issues 57 product-specific guidances, including 19 laying out path for developing generics to hard-to-copy “complex” medicines

Unapproved New Drugs/Misbranded

The Food and Drug Administration is advising consumers not to purchase or use VITALITY, a product promoted and sold for sexual enhancement on https://www.zen-herbs.com and possibly in some retail stores.

Akorn Pharmaceuticals Inc. Decatur, IL. 483 Issued 06/10/2016

KRASNIY OKTYABR INC. USA. of BROOKLYN, NY, is recalling its “ARAL SILVER VOBLA” brand “ARAL”, because the product was found to be uneviscerated.

Gina Marie Bakery of Waterbury, CT is recalling 1lb and 2 lb packages of the above-mentioned cookies because they contain undeclared allergens. People who have allergies to nuts, sesame seeds and/or food dyes run the risk of serious or life-threatening allergic reaction if they consume these produc

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.