Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for pati
Similar Posts
Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment
Myelodysplastic Syndromes: Developing Drug and Biological Products for TreatmentW.W. Industrial Group Recalls Pear Slices in Juice Due to Elevated Levels of Lead and Cadmium
W.W. Industrial Group, Inc., NY is recalling Parashore Pear Slices in juice, 15 oz, because they have the potential to be contaminated with elevated levels of lead and cadmium.CDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data—may offer ways to reduce animal testing.New Hoque & Sons Inc Issues Alert on Uneviscerated “Dry Ghoinnya Fish”
New Hoque & Sons Inc. of Maspeth, NY, is recalling its packages of “Dry Ghoinnya Fish” because the product was found to be uneviscerated.The recalled “Dry Ghoinnya Fish” were distributed nationwide in retail stores. The product comes in a 10-12 pound, clear plastic package marked with an expiratiFDA In Brief: FDA issues draft guidance to foster oncology product development for pediatric populations
FDA issues draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.” The draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs.Jody’s Inc. Recalls Cabot Creamery Sea Salt Caramel Cheddar Popcorn Due to Undeclared Peanuts
Jody’s Inc. is recalling Cabot Creamery Sea Salt Caramel Cheddar Popcorn 6 oz (170 g) bag, lot number 2519907B1, Best If Enjoyed By: 07 15 26 UPC 8 50016 95530 6, due to presence of undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threa