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The trial results showed the combinations did not significantly increase the risk of asthma-related hospitalizations, intubations or asthma-related deaths. Read More
The FDA removed its Boxed Warning regarding asthma-related death from the labels of medicines containing long-acting beta agonists in combination with inhaled corticosteroids, following postmarket studies of possible side effects. Read More
The European Medicines Agency should upgrade its user testing of drug packaging inserts and other product information for patients over the next 18 months in carrying out recommendations from the European Commission, the agency said in an action plan. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
Parts of the FDA’s recently updated draft guidance on the content and formatting of REMS documents are overly prescriptive, stakeholders said in public comments to the agency. Read More
The European Medicines Agency launched the new version of its EudraVigilance adverse event database Nov. 22, providing more tools for analysis. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
Most drugmakers are fulfilling their postmarketing study commitments, but many are not meeting their deadlines for annual status reports, the FDA said. Read More