Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product...more
The Queen's Speech, which set out the government's proposed plan for new legislation, included a new "Medicines and Medical Devices Bill". The government's background briefing describes the purpose of the Bill as ensuring...more
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more
In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more