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Finalized guidance on preclinical considerations for gene and cellular therapies, posted Monday, reiterates the agency’s position that sponsors should focus on five objectives in preclinical trials. Read More
Today’s regulatory culture is too risk-averse when it comes to drug approvals and risks keeping promising treatments off the market, senior officials at the European Medicines Agency say. Read More
The European Medicines Agency will accept premarket applications with limited data for antibiotics that target unmet needs, according to an amended guideline on developing antibacterial drugs for multidrug-resistant infections. Read More
To improve compliance in clinical trials, investigators need to find ways to accommodate individual patient needs and help trial participants understand the rationale behind protocols, an industry report says. Read More
Sponsors of medical device clinical trials should avoid recruiting and putting at risk an unnecessarily large number of patients, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
CDER Director Janet Woodcock said Nov. 15 that she supports the creation of a swift-approval pathway for antibiotics that target limited patient populations. Read More
Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More
Clinical investigators need to improve adherence to study protocols and maintain better records of their trials, according to findings from an FDAnews-sponsored study. Read More
Researchers writing in the New England Journal of Medicine are calling for a more risk-based approach to regulating clinical trials and changes to regulatory systems, with the aim of removing unnecessary hurdles to medical research. Read More
As drug sponsors make their way through the EU approval process, there are “triggers” that can help European Medicines Agency inspection coordinators determine whether a clinical trial should undergo a routine or for-cause good clinical practice inspection, an agency working group says. Determining factors include trial size, complexity and site selection. Read More
Investigators contemplating their own clinical trials need to understand the regulatory framework of investigator-initiated studies and what it means to be a sponsor investigator before wading into the water, a legal expert says. Read More