Administration’s proposed fiscal year 2013 spending plan includes $4.5 billion for FDA, with $2 billion or 44% provided by various user fees.
FDA expects that it will receive $20 million in user fees for biosimilar products in fiscal year 2013, enabling it to hire 68 employees for its biosimilars program.
Of the total, $11.8 million and 45.5 full-time equivalent staffing slots would be targeted for application reviews, including activities related...
Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
