News & Analysis on Clinical Trial Services & Contract Research And Development
Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in a report on 2013 inspections.
An analysis of clinical trial data by Medidata and industry group TransCelerate BioPharma has found that the value of source document verification (SDV) in a risk-based approach to clinical trial site monitoring is minimal.
UK life sciences minister George Freeman wants hospitals to play more of a role in clinical trials and says accelerating the drug development process in the post block-buster era is key for Big Pharma and patients.
The US FDA and the Federal Trade Commission have sent warning letters to two companies claiming to have drugs that treat Ebola though no such product has been approved by the agency.
A preclinical biotech backed by Bristol-Myers Squibb is forming a strategic alliance with Synergy Partners R&D Solutions to boost academic discoveries.
Dispatches from the FT Global Healthcare and Biotech Conference
The EMA is “caught between a rock and a hard place” in expediting drug development, but an agency Executive says change can come through its new adaptive licensing pathway.