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In the next few years, drugmakers will have to collect quality metrics data for FDA investigators to use in determining a facility’s quality status. Metrics being bandied about include batch failure rates, CAPA rates, complaints and right-first-time rates. Read More
Drugmakers seeking approval of genetically engineered products must begin submitting an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More
The European Medicines Agency has greenlighted AbbVie’s Humira for the treatment of severe chronic plaque psoriasis in children and adolescents who have had an inadequate response to or are poor candidates for topical and photo therapies. Read More
Roche adequately warned of the risks of ingesting acne drug Accutane after April 10, 2002, a New Jersey judge ruled last week, resolving lawsuits filed by people in the state who used the product since that date. Read More
The FDA’s Office of Prescription Drug Promotion wants to know how consumers perceive drugmakers’ comparisons of pricing and efficacy information in advertisements. Read More
The Centers for Medicare & Medicaid Services has announced that it plans to begin paying for biosimilars through its Part B, Part D and state coverage policies by this summer. Read More
The guideline specifies not only that covariates should be included in the primary analysis but also that sponsors should justify which ones they include. Read More
More new drugs are winning approval on their first FDA review than at any time in the last seven years, a review of the agency’s performance has found. Read More