International Pharmaceutical Regulatory Monitor
September 2011 | Vol. 39 No. 9 | Full Issue in PDF Format
Global revenues for contract pharma manufacturing will exceed $64 billion in 2016, according to London-based business analysis company visiongain. Driving that growth will be production of finished dosage forms, the company’s report, Pharmaceutical Contract Manufacturing: World Market Outlook 2011-2021, states.
Drugmakers redeeming a U.S. Food and Drug Administration (FDA) tropical disease priority review voucher in fiscal 2012 would pay about $5.3 million in addition to the standard user fee, the agency says.
Japan granted funding to several domestic companies to build H1N1 influenza vaccine manufacturing capacity.
The European Commission expanded the indication for Novartis’ Afinitor to include treatment of advanced pancreatic neuroendocrine tumors (PNET).
To ensure Japanese-made medicines carry no risk of radioactive contamination, European regulators are working with international regulators on tests running through Sept. 30.
The European Medicines Agency (EMA) is discussing the role genomic biomarkers (GBMs) might play in predicting which patients could benefit from or experience side effects of a medicine. Includes the full text of EMA Reflection Paper Examines Biomarker Role in Drug Development.
The European Medicines Agency (EMA) has new validation criteria for electronic applications.
Latin American investigators prefer pharmaceutical companies over contract research organizations as managers of day-to-day clinical trial operations, according to a report.
The U.S. Food and Drug Administration (FDA) is adopting a new International Conference on Harmonisation (ICH) guidance outlining the format, content and timing of development safety update reports (DSURs) to harmonize safety reporting for investigational drugs.
Facebook no longer will allow drug- and devicemakers to disable the capability to post comments, including adverse event descriptions, on community-focused Facebook pages.
A new tax law will make Australia more globally competitive in pharmaceutical research and development (R&D), according to the drug industry.
To ensure access to new medicines, Australia needs a predictable regulatory and reimbursement environment, according to a pharmaceutical industry representative.
Clarification of regulatory requirements and internal review standards for neglected tropical disease (NTD) drug approvals in the U.S. appears in a U.S. Food and Drug Administration (FDA) draft guidance.
Sponsors should use centralized monitoring and risk-based approaches to oversee clinical investigations, a new draft guidance from the U.S. Food & Drug Administration (FDA) advises.
The European Commission (EC) approved Roche’s Tarceva for first-line use in patients with a genetically distinct form of non-small cell lung cancer (NSCLC).
Johnson & Johnson and Bayer AG’s oral anticoagulant Xarelto should not get U.S. Food & Drug Administration (FDA) approval to prevent strokes and systemic embolism in patients with non-valvular atrial fibrillation (AF), according to an FDA briefing document prepared for the agency’s Cardiovascular and Renal Drug Advisory Committee (CRDAC).
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