The Vaccine Adverse Event Reporting System (VAERS), co-managed by CDC and the Food and Drug Administration (FDA), is the national postmarketing safety monitoring system that accepts reports about adverse events that occur after administration of U.S.-licensed vaccines (1,2). On June 30, 2017, CDC and FDA implemented a revised reporting form and a new process for submitting reports to VAERS. Per...

The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA...

Ibrutinib (USAN, also known as PCI-32765 and marketed under the name Imbruvica) (Figure 1) of formula C25H24N6O2 and molar mass 440.497 is an anticancer drug targeting B-cell malignancies. It was approved by the US Food and Drug Administration (FDA) in November 2013 for the treatment of mantle cell lymphoma and in February 2014 for the treatment of chronic lymphocytic leukemia. Ibrutinib is cur...

Ruxolitinib, a small molecule JAK-1/2 inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in November 2011, as the first therapeutic for the treatment of intermediate and high-risk myelofibrosis. The Janus kinase/signal transducers and activators of transcription (JAK/STAT) pathway is one of the most well-studied intracellular signaling networks. Recent advances in our unders...

O brentuximab vedotina está aprovado pela Food and Drug Administration (FDA) e European Medicines Agency (EMA) para o tratamento de doentes adultos com linfomas cutâneos primários células T CD30+, refratários a pelo menos uma linha terapêutica prévia. Os autores reportam dois casos clínicos linfoma cutâneo primário grandes anaplásicas, tratados vedotina, respostas clínicas distintas. Não obstan...

I propose to raise funds for postapproval studies of long-term drug safety by augmenting the existing "user-fee" system. Fees would be raised by an amount deemed optimal for revenue collection, and the U.S. Food and Drug Administration (FDA) would direct the incremental funds to a combination of randomized controlled trials, epidemiological studies, and postmarketing surveillance. User-fee augm...

Generic substitution of antiepileptic drugs remains a controversial area without a clear consensus to guide clinicians. The US Food and Drug Administration (FDA) requires rigorous testing of generic products and states that all approved products are interchangeable. FDA studies involve single doses in normal subjects so may not represent the performance of generic products in people with epilep...

Contamination of food by chemicals can result from their use on agricultural commodities; accidents or misuse during food handling and processing; nucler weapon testing and operation of nuclear power plants; and disposal of industrial chemicals or by-products with subsequent dispersal into the environment. The Food and Drug Administration (FDA), as the Federal agency mainly responsible for eval...

Digital Object Identifier: 10.1188/05.CJON.113-114 PC-SPES is an herbal supplement containing eight Chinese herbs (see Table 1). PC stands for prostate cancer, and spes is Latin for hope. PC-SPES was formulated according to traditional Chinese medicine principles involving ingredients that may counteract cytotoxic agents, minimize toxicity, and reduce the development of drug resistance in targe...