We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Japan on Wednesday launched a new government agency to spearhead medical research and drug development through partnerships with industry and academia. Read More
Drugmakers operating in New Zealand must begin creating safety signal management processes for every drug they distribute to satisfy the country’s drug regulators. Read More
Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to Wednesday guidance that sets specific timelines for every step of the dispute resolution process. Read More
The FDA is giving industry and other interested parties another 30 days to weigh in on its request for suggestions on new biomarkers to speed drug development, according to an FDA notice. Read More
The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. Read More