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The European Medicines Agency recommended eight new drugs for approval, including two combination treatments for hepatitis C, two therapies for advanced cancers and one drug for relapsing multiple sclerosis. Read More
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More
The European Medicines Agency published a step-by-step guide for drugmakers to prepare for the implementation of the new EudraVigilance adverse event monitoring system, scheduled for Nov. 22. Read More
The European Medicines Agency says marketing authorization holders must be based in the European Economic Area post-Brexit — and UK-based companies will likely need to transfer marketing authorizations to new addressees. Read More
The Supreme Court of Canada struck down the “promise doctrine” used in the evaluation of a patent’s validity — a victory for the pharmaceutical industry, which said its use has led to the cancellation of over two dozen drug patents in the country over the past ten years. Read More
China has joined the ICH as its eighth regulatory member, pledging to gradually transform its pharmaceutical regulatory authorities, industry and research institutions to implement the international coalition’s technical standards and guidelines. Read More
The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties. Read More
Officials from Kentucky, Maryland, Rhode Island and Virginia testified to a house committee yesterday about the opioid epidemic in their states and asked for more assistance to combat the problem. Read More
The House passed its version of the FDA user fee reauthorization package Wednesday that is expected to bring in $1.42 billion in fiscal 2018, by a voice vote. Read More
The House Appropriations Committee on Wednesday approved a bill by voice vote that would provide a total of $5.2 billion for the FDA in fiscal 2018—$2.6 billion in discretionary spending with the remainder coming from user fees. Read More
The products include HIV antiretroviral therapies and combinations, a treatment for major depressive disorder and a chemotherapy approved in non-small cell lung cancer. Read More
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More