High turnover rates among clinical research associates (CRA) continue to plague the industry – and competence and staff engagement are the "crux" of the issue, says IAOCR.
The US FDA has told Wockhardt its quality issues are company-wide, citing problems at subsidiary Morton Grove as an example in a warning letter published today.
The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths.
The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed this week.
UDG’s Ashfield division will use Salesforce Health Cloud to help outsource clients launch therapies into EU and US markets through “seamless” data exchange.
The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.
Particulate problems in sterile injectables and poor aseptic techniques landed Pfizer with a US FDA warning letter at a former Hospira facility in Kansas.
Premier Research has selected ERT’s Trial Oversight suite as its clinical trial management solution to augment sponsor collaboration and help mitigate risk.
Pharma Outsourcing & Partnership Global Congress 2017 Europe
Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to ClinicalTrials.gov – and ultimately, study start up.
Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.
The CRO JSS Medical Research will use EnduraData’s cloud tool to synchronize medical research data between servers in Canada and Colombia, South America.
A radiopharmaceuticals plant is the most likely source of the radioactive iodine-131 detected in several countries in recent weeks according to experts.
The EMA recently updated its Good Clinical Practice (GCP) Q&A to address several contractual arrangement “pitfalls” – specifically with electronic systems vendors.
The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.
Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.
Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.
The Association of Clinical Research Professionals (ACRP) has published a new guidance addressing the standardization of competence required for clinical trial monitors.
Antares Vision is expanding at a larger facility to help meet customer demand ahead of looming regulatory deadlines, which have driven its investment and growth.
Indian regulators want manufacturers to discourage pharmacists from selling antibiotics to patients without prescriptions as part of an effort to curb the spread of superbugs.
Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.
DHL Global Forwarding is opening four new temperature-controlled storage chambers in San Juan this year after investing nearly $1m in the market in 2016.
If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).
Almac Group has launched a GDP-compliant web-based platform, TempEZ, to provide customers with a single database to store temperature data from the manufacturing stage to patient administration.
The GMP certification of a Dutch cannabis production facility is a “major step” in bringing medicinal marijuana to the level of evidence based medicines, says Bedrocan.
Porton Biopharma says it is undergoing a manufacturing review to address US FDA concerns about the production of Jazz Pharmaceuticals’s orphan drug Erwinaze.
Schulman IRB is integrating its WebPortal platform with Veeva’s eTMF solution to offer real-time IRB status updates and approval documentation to clients.
Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.
ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.
Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.
