Fear of lawsuits and customer confusion have greeted a Food and Drug Administration plan to let generic drug companies change labels quickly, without prior agency approval, when they learn of adverse effects once the generic reaches the market.

In clinical trials, pharmaceutical companies test the efficacy and safety of a new drug for the treatment of a disease by comparing the results from a large number of diseased and healthy patients exposed to either the new drug, an existing drug that treats the disease, or a placebo. One primary concern is liver toxicity, which is usually diagnosed by blood analyte tests. Often, such signals of...

In 2009, we examined 104 new brand name products or new indications for existing products in the French edition of Prescrire. Only 3 of these 104 "innovations" provided some therapeutic advantage, while 19 had clearly unfavourable risk-benefit balances. Marketing authorisations are failing to adequately protect patients. A number of cheaper generic versions of useful drugs were introduced to th...

Drug companies may be required to report shortages sooner, but the FDA legislation still lacks power.

BACKGROUND Drug manufacturer rebates paid to health plans and pharmacy benefit management companies have come under increased public scrutiny. Over the past several years, numerous articles have appeared in the literature encouraging a shift to a more quality-based decision-making process for health plan drug formularies. OBJECTIVE To propose a new basis for formulary placement decisions that...

OBJECTIVE To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. METHODS We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug M...

Market pressures and reassess their current drug development model drugs by pharmaceutical companies to tap into new and innovative business models that have driven. Converter is used in medicine as a variety of techniques lend themselves to distributed computing model. Cloud optimizes resource usage and various pilot projects into pharmaceutical companies that reflect the current trend of a co...

he number of products based on new drug delivery systems has significantly increased in the past few years, and this growth is expected to continue in the near future. Recent advances in the field of genomics have accelerated research of biopharmaceuticals, and today a large number of companies are busy developing proteinand peptide-based drugs. These biopharmaceuticals present challenges to dr...