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Difficulties finding the right patients for clinical trials and high active pharmaceutical ingredient costs are among the most pressing challenges in bringing new antibiotics for resistant infections to market. Read More
The number of clinical trials in India is rebounding after plunging precipitously in recent years following the government’s imposition of strict new regulations on the clinical trial industry. Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More
The FDA hopes to spur development of pediatric rare disease treatments through a series of forthcoming guidances that will address issues such as how to conduct clinical trials for pediatric oncology products and common challenges in developing rare disease treatments. Read More
A European public-private partnership is launching a new $4.5 billion decade-long effort to improve the success rate of clinical trials on certain drugs by 30 percent and boost exclusivity to make manufacturing treatments more enticing. Read More
Multiple lapses in informed consent and institutional review board procedures landed an FDA warning letter for clinical trial sponsor Rogerio Lobo, a physician in the Department of Obstetrics and Gynecology at Columbia University Medical Center in New York City. Read More
A Georgia clinical investigator was warned by the FDA for failing to properly randomize and dose patients participating in a GlaxoSmithKline study evaluating albiglutide in patients with type 2 diabetes. Read More
Not all clinical trials need to be registered on clinicaltrials.gov, so sponsors need to understand the specific elements that determine if their trial is applicable to those reporting requirements, an expert says. Read More
The Duchenne muscular dystrophy community wants the FDA to consider patients’ and caregivers’ views when conducting risk-benefit analyses in clinical trials of new treatments for the disease. Read More
The Therapeutic Goods Administration is considering adopting 15 EU guidelines relating to drug development, including guidance on biosimilars, lipid disorder therapies and bacterial infections. Read More
Sponsors in India are calling for the government to settle a prolonged lawsuit over clinical trial deaths, a move experts say could revive trial activity in the country. Read More