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February 19, 2020
US and European regulatory officials continue to anticipate supply shortages in multiple areas.
February 18, 2020
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of cyproterone be restricted as a result of the potential risk of meningioma.
February 17, 2020
FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.
The agency is taking steps to monitor the supply chain and assist in the development of treatments.
February 13, 2020
The National Institute for Health and Care Excellence (NICE) has issued guidance in Feb. 2020 stating that it does not recommend the combination therapy of pembrolizumab with axitinib for the treatment of advanced renal cell carcinoma in adults.
February 12, 2020
The report details OPQ’s accomplishments over the past five years.
February 06, 2020
The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.
The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.
FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.
February 05, 2020
The FDA Commissioner plans to address drug prices, the drug approval process, and supply chain issues during his time as commissioner of FDA.