Atrial fibrillation (PDF file)
EMA draft guidance on conducting trials for products to prevent stroke and systemic embolic events in patients with non-valvular atrial fibrillation (AF) (see BioCentury Extra, Monday, Nov. 18).
Clinical effectiveness research (PDF file)
Patient-Centered Outcomes Research Institute (PCORI) revised methodology on conducting comparative clinical effectiveness research (see BioCentury Extra, Tuesday, Nov. 19).
Text of the Drug Quality and Security Act of 2013 passed by the U.S. Senate, which would allow voluntary oversight of compounding pharmacies by FDA and create an electronic, unit-level system for tracking and tracing pharmaceutical products (November 25, 2013).
IMS report predicting that global spending on drugs will reach about $1.2 trillion in 2017, up from $965 billion in 2012 (see BioCentury Extra, Tuesday, Nov. 19).
EMA (PDF file)
EMA and the European network for Health Technology Assessment (EUnetHTA) work plan, in which the organizations said they will focus on generating data to support decision making by both regulators and health technology assessment (HTA) organizations (see BioCentury Extra, Wednesday, Nov. 20).
New England Journal of Medicine article from NIH Director Francis Collins and FDA Commissioner Margaret Hamburg, which said that approval of a non-disease specific sequencing platform will "expand the incorporation of genetic information into health care" and is a "significant step forward" in personalized medicine (November 25, 2013).
Orphan Drugs (PDF file)
Summary of actions taken at the Nov. 5-6 meeting of EMA's Committee for Orphan Medical Products (COMP).
Pharmacovigilance (PDF file)
Recommendations adopted at the Oct. 7-10 meeting of EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Rare diseases (PDF file)
The U.K. Department of Health's strategy to improve research and services for patients with rare diseases.
Research and innovation
EU's Horizon 2020 research and innovation program for 2014-20, which the European Parliament approved (PDF file)with a budget of EUR 78.6 billion ($106.1 billion) (see BioCentury Extra, Thursday, Nov. 21).
Risk (PDF file)
Nature Reviews Drug Discovery perspective article from current and former officials at EMA and the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), which said that drug regulators, including EMA, may be too risk averse and should consider patients' willingness to accept risk along with the opportunity costs of not approving a drug when evaluating the risk/benefit profile of a product (see BioCentury Extra, Tuesday, Nov. 19).