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Drugmakers can now make minor changes to drug safety assurance plans without waiting for FDA approval, reducing some of the burden of managing risk evaluation and mitigation strategies. Read More
Drugmakers exporting drugs from India must now include barcodes on all tertiary and secondary packaging. The policy, intended to assure the safety and effectiveness of therapies reaching patients in the U.S. and elsewhere, affects drugs made on or after April 1, 2015. 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
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
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