The potency and purity of compounded preparations of ketoprofen, amikacin, and boldenone were highly variable compared with Food and Drug Administration (FDA)-approved preparations of these drugs. These differences in concentration and purity could have important consequences for the efficacy and safety of the drug.

1 National Cancer Institute, Frederick, Maryland, United States of America. 2 University of California, School of Public Health, Irvine, California, United States of America. 3 Center for Drug Evaluation, Food and Drug Administration (FDA) Silver Spring Maryland, United States of America. 4 National Cancer Institute, Bethesda, Maryland, United States of America. 5 MD Anderson Cancer Center Hous...

Methodology has been proposed for evaluating switchability of two formulations of a drug that encompasses bioequivalence aspects using Dragalin and Fedorov’s application of the KullbackLeibler Divergence (KLD) and a metric developed by the Food and Drug Administration (FDA) as measures of discrepancy between the distributions of the two formulations using two sequence replicate, crossover desig...

DOI: 10.5935/abc.20160009 In the first semester of this year, the U.S. Food and Drug Administration (FDA) approved a new drug for the treatment of heart failure, LCZ696, commercially known as Entresto. This new treatment option was evaluated by the FDA on a priority basis (fast track designation), which allowed a faster release than usual. In Brazil, the drug is being evaluated by the National ...

Calendula officinalis Linn. commonly known as marigold has long history of usage by the folklore system. It has a high economic value as herbal medicine and is widely used in cosmetics, perfumes, dyes, pharmaceutical preparations and food products for centuries. The plant has been approved for food use and appears in the food and drug administration (FDA) list of generally recognized as safe (G...

This letter is in reference to the court decision directing the Food and Drug Administration (FDA) to reconsider the health claim “Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease” in dietary supplement labeling (Pearson v. Shalufu, 164 F.3d 650 (D.C. Cir. 1999)). FDA has sent you replies on two of the other health claims that the court directed FDA to reconsider...

I n 2007, President George W. Bush signed into law the Food and Drug Administration Amendments Act (FDAAA) (121 Stat 962). This Act, by adding subsection (k)(5) to section 505 (21 USC §355), directed the Food and Drug Administration (FDA) to “conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the AERS Website of any new safe...

D h n a p F s i ( t m s p t n t n d f r C i i l rom Clinical Pharmacology, AstraZeneca, Mölndal; Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis; Department of Biology (Galton Lab), University College London, London; Center for Drug Evaluation and Research, Food and Drug Administration, Rockville; School of Pharmacy, University of California San Francisco,...

BACKGROUND A rise in popularity of cosmetic tattoos has led to an increase in adverse reactions. Due to more pressing concerns, the Food and Drug Administration (FDA) has not traditionally enforced its authority over tattoo inks. OBJECTIVE To raise awareness of the dangers of cosmetic tattoos. MATERIALS AND METHODS We reviewed FDA policies regarding tattoo ink, different ink components, adv...