The US FDA’s New Inspection Protocol Project represents an “improvement process step” towards a risk-based site selection model, according to the Swedish CDMO.
The FDA recently released open source code and technical documents for its new mobile app – MyStudies – which is designed to collect information about medication use, health system touchpoints, and patient-reported outcomes.
The new recommendations look to provide a more efficient and effective means of qualifying clinical trial investigators – to help teams ‘conduct better, more efficient clinical trials,’ says CTTI exec.
WHO recently assessed Biopharma Services, which demonstrated compliance across multiple regulatory and organizational guidelines – opening the doors to conduct more work with the WHO foundations.
Dr. Reddy’s Laboratories site in Visakhapatnam, India, was issued a Form 483 last month, yet shares rose after a more recent audit where zero observations were noted.
The FDA has proposed a study to create a non-animal based model for drug development as part of its overall commitment to reduce the number of animals used in research.
The MA-based CRO Veristat is partnering with Triumph Research Intelligence to provide centralized and risk-based monitoring solutions to improve clinical trial compliance.
Sandoz is the latest Zhejiang Huahai Pharmaceutical customer to issue a nationwide recall after trace amounts of a probable carcinogen were found in the supplier’s API.
With less than one month until the US DSCSA deadline, RAPS member Greg Cathcart says the biggest concern for firms is understanding what is required, and when.
Vertex was granted marketing authorization for its cystic fibrosis therapy in a combination regimen, marking the company’s third treatment for the condition to reach the market.
After Pharm-Olam conducted an orphan disease trial for therapy for a rare blood disorder, the European Commission granted it marketing authorization, and FDA is to give it priority review.
The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations.
ScieGen Pharmaceuticals has recalled certain batches of hypertension drug irbesartan, after a probable carcinogen was detected in supplier Aurobindo’s API.
President Donald Trump signed the SUPPORT act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn’t the only crisis.
The FDA’s recent guidance on complex generics ‘increases clarity’ for Indian drugmakers targeting the US market, according to India Ratings and Research.
Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.
New guidances from the FDA update language and provide clarity for innovative approaches to the design and execution of clinical trials, say industry executives.
The FDA is calling on the digital health industry to innovate and proposing a new Center of Excellence for Digital Health – the timing of which is critical, as the industry is receiving more funding and opportunities than ever before, says industry exec.
According to the US FDA, a facility inspection revealed operators leaned their heads and torsos over open containers while clearing bottle jams, before restarting the aseptic line.
The recent FDA guidance ties penalties for not disclosing clinical trial results to formal inspections – falling short of the public expectation that such data should be readily available, says industry expert.
Insmed has become the first company to receive approval through the limited population pathway for antibacterial and antifungal drugs set up by the US FDA in 2016.
The US FDA has issued a warning letter to contract testing laboratory Pharmaceutical Laboratories and Consultants, Inc., after a microbrewery was found to be operating in shared space.
