While approved last year, it does not apply earlier than May 2016—leaving interested parties only nine months to prepare for its arrival.
TransCelerate recently announced a new initiative focused on eLabeling in clinical trials. The eLabels Initiative is expected to improve label usage for patients, streamline labeling approaches at sites and create opportunities to decrease timelines in the investigational supply chain resulting in cost efficiencies for sponsors.
The FDA works to protect public health by balancing the requirements for extensive safety and efficacy data prior to approval, and the need to expeditiously issue approval decisions to ensure medicines that could save or dramatically improve patients’ lives are available as soon as possible.
An analysis by Life Science Compliance Update of the U.S. government's Open Payments database shows that industry spending on U.S-based clinical research has dropped 32% in the first year-over-year comparison since Open Payments data started to be collected.
How can you navigate the regulatory triangle safely?
The Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan.
To mark the 50th anniversary of the adoption of the first European Union (EU) pharmaceutical legislation, the European Commission is organizing a one-day conference that will take place in Brussels September 28.
Navitas, a regulatory service provider, announced that it has opened a new Latin America hub in Bogota, Colombia. Navitas' expansion into Latin America offers bilingual resources (Spanish and English) and provides document, report and submission level publishing for simple and complex submission applicatioms.