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In an effort to head off one of the most common problems that sidetracks ANDA submissions, the FDA is telling drugmakers that bioequivalence studies for most drugs submitted as ANDAs should use a two-period, two-sequence, single-dose, crossover study design. Read More
Devicemakers seeking regulatory approval in the U.S. are strongly urged to blind patients and investigators in pivotal clinical trials, when possible, according to final guidance issued by the Food and Drug Administration. Read More
Medtech sponsors should balance the need to demonstrate safety and efficacy with the potential risks to patients when determining the size and duration of a clinical trial, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
In the latest effort to clean up India’s troubled clinical trial industry, the government is requiring that clinical investigators video record the informed consent process with each study subject. Read More
Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More
New technology and anxiety over expiring patents have driven pharma to triple clinical development of large molecule and biologic drugs over the past decade, says an industry expert. Read More
The FDA and Vanda failed to agree on a prespecified primary endpoint for the new sleep disorder drug, tasimelteon, but that didn’t derail the company’s NDA. Read More
The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More
In the latest initiative to clean up its troubled clinical trial industry, the Indian government is requiring investigators to video record the informed consent process for each subject in clinical studies. Read More
Despite not agreeing on primary endpoints with the FDA before beginning clinical trials for a new sleep disorder drug, Vanda was able to get an almost unanimous recommendation from an advisory committee earlier this month. Read More
Medical devicemakers should avoid recruiting and putting at risk an unnecessarily large number of patients in clinical trials, the UK’s Medicines and Healthcare products Regulatory Agency says in one of five trial-related guidances issued last month. Read More