A little more than a year after the FDA approved Kalydeco (Vx-770), the first drug of its kind to treat the underlying cause of cystic fibrosis, University of Missouri researchers believe they have found exactly how this drug works and how to improve its effectiveness in the future. Described in...
Functional somatic symptoms (FSS) are physical complaints, such as headaches, pain, fatigue, and dizziness, that cannot be explained medically. These symptoms affect 10-30% of children and adolescents and account for 2-4% of all pediatric doctor visits. A new study scheduled for publication in...
In Alzheimer's disease, brain neurons become clogged with tangled proteins. Scientists suspect these tangles arise partly due to malfunctions in a little-known regulatory system within cells. Now, researchers have dramatically increased what they know about this particular regulatory system in...
Angiogenesis, the growth of new blood vessels, is a complex process during which different signalling proteins interact with each other in a highly coordinated fashion. The growth factor VEGF and the Notch signalling pathway both play important roles in this process. VEGF promotes vessel growth...
Pharmaceutical Regulatory Writing & Submissions Conference, 14-15 May 2012, Baltimore
This May, Q1 Productions will host leaders and innovators from pharmaceutical and biotechnology industries in Baltimore to discuss challenges and following with management strategies to best navigate the...
2nd Annual Clinical Affairs & Regulatory Approvals For Diagnostics, September 12-13,
Understanding Changes to FDA Regulatory Pathways and the Relative Evidentiary Requirements, Identifying Sample Size and Trial Design for Successful Submissions for Diagnostic Clinical Studies As diagnostic...
Medical Device Regulatory Clearance & Approval Conference, September 12-13 2011, Balt
Providing Clarity & Definition to New & Existing FDA Regulatory Pathways to Ensure Medical Device Approvals in a Timely & Cost Efficient Manner There is no doubt that the medical device industry is currently...
Janssen-Cilag International NV announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of ZYTIGA® (abiraterone acetate) under an accelerated regulatory review procedure. ZYTIGA is a...
Two articles in the June issue of The Journal of Nuclear Medicine make a case for maintaining current U.S. Nuclear Regulatory Commission (NRC) regulations on the release of patients who undergo radioactive iodine treatments for thyroid cancer. Currently, the NRC recommends outpatient treatment...
Pharmaceutical companies with good track records of approvals and first approvals are characterized not only by strong science but also strong working relationships with the FDA. Regulatory Affairs is the function that oversees and guides interactions with the FDA it's a job that comes with a...
An international team of senior nuclear safety experts have completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the United States. The team identified good practices within the U.S. system and offered...
GlaxoSmithKline (NYSE and LSE: GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has announced their individual regulatory decisions and the resulting actions. In the...
The Canadian Food Inspection Agency (CFIA) is seeking input from stakeholders and the Canadian public on the proposed principles that will guide the development of new regulations for certain imported food products. This would include enhanced food safety requirements as well as an importer...
Endo Pharmaceuticals (Nasdaq: ENDP) has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company's receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel. The...
When a pharmaceutical company wants its new drug on the market, it must first submit mountains of paperwork to regulatory agencies like the US Food & Drug Administration (FDA)-most of it scientific articles describing the drug's properties. Gathering these articles can be time-consuming...