News & Analysis on Clinical Trial Services & Contract Research And Development
The rule designed to increase protection for clinical trial participants was set to go into effect next month, but another delay announced today has pushed this date back an additional six months.
Greenphire is partnering with Lyft to enable clinical trial site coordinators to secure rides and reimburse study participants.
GE has introduced a new high capacity system designed to improve productivity in the increasingly complex drug discovery process.
Real-world evidence, digital endpoints, and patient centricity are among the top trends in clinical trials – the benefits of which will be realized in part through advances in eClinical technology.
This year’s DIA Global Annual Meeting will focus on the latest global trends and showcase the "diverse group of key individuals driving the life science ecosystem forward," says DIA Americas managing director.
Mylan says ‘minor deficiencies’ in its abbreviated new drug application for its proposed generic version of GSK’s Advair Diskus have prompted the US FDA to issue a complete response letter.
The US FDA has rejected Valeant Pharmaceutical International’s investigational topical treatment for plaque psoriasis, Duobrii.
Drugmakers can greatly profit from developing a combination drug, but must address manufacturing and regulatory challenges in the early development stage, says Pharmatech Associates.
Providing a coherent and persuasive risk assessment and a “well-messaged outline of key communication points” are key to winning US FDA Advisory Committee approval, say industry consultants.
The drug development “finish line” is not regulatory approval, says Syenos Health chief scientific officer Judith Ng-Cashin, MD, who discusses bringing the payer and patient voice into the process.
News in brief
DSP has released its generic Atorvastatin drug product within the EU with additional markets to be added later this year the firm looks to become a full-service generics company.