In the U.S. generic companies can sell off-patent products immediately, but they have to compensate the company that originally registered the chemical with the Environmental Protection Agency--Monsanto in this case--for the data showing the product's safety and efficacy.

FORBES: Pesticide Prince

The day before the opening today of the ASH conference in Atlanta, TG Therapeitics announced it has initiated a phase 1 and 2 clinical trials to evaluate the safety, tolerability and efficacy of its product, TG-1101, a novel third-generation anti-CD20 monoclonal antibody, in combination with Revilimid for patients with relapsed or refractory B-cell lymphoid malignancies who were previously treated with anti-CD20 antibody therapy.

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But since folic acid is suspected of enhancing the efficacy of the Merck product, including it caused few qualms.

ECONOMIST: Trial and error

Quality directly impacts the efficacy of the finished product.

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Moreover, he argues that most of the omissions can be explained by the focus of the published paper and the increased scrutiny Medtronic gave data before they were submitted to the FDA. He says that the product label for Infuse accurately reflects its safety and efficacy.

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