Planning for partnering, mergers and acquisitions must be done carefully, particularly if you need to prepare scientific, technical and regulatory information about complex therapeutic products. Generating such information may be the duty of the seller, but it is the buyer’s job to assess the opportunities.
Over the course of the last two decades, the healthcare industry has witnessed the digitization and consolidation of data to improve scientific research. In the past, information was siloed, disparate, and focused on health claims data. Today, digital health systems are turning to representative
The global supply chain impacts of COVID-19 highlighted the urgent need for disruptive technologies to strengthen the agility and resilience of the pharmaceutical value chain network. Fortuitously, in parallel the ISPE's Pharma 4.0 framework
Clinical trials (CT) are the long and complex processes for bringing novel medical products to patients through the regulatory process of evaluating the safety and efficacy of treating specific medical conditions in humans. In addition to the challenges associated with adult clinical trials, there are unique challenges in conducting pediatric clinical trials.
Protein biomarkers may be a single protein or a panel of multiple proteins that help diagnose illness, inform prognosis and monitor a patient’s biological response to treatment.
Imagine being asked to board a flight after learning that there were no air traffic controllers available to communicate with the pilot. The idea is ludicrous because it would never happen.
Traditional healthcare delivery has been on its way out for well over a decade now, as patient outcomes and measurable value have increased in importance.
The European Medicine Agency's (EMA) decision is the latest turn of events in an Identification of Medicinal Products (IDMP) rollout saga that has been dragging on for years.
Progress toward the 2023 Drug Supply Chain Security Act (DSCSA) requirement for full product serialization is uneven, with some progress and obstacles appearing as healthcare supply chain partners implement the data requirements.
We are amid a worldwide lung crisis. In the 40 years prior to COVID, lung disease mortality grew by 40%, while the mortality rate for other major diseases all decreased.
In January 2022, the European Medicines Agency (EMA) communicated their plans for Digital Application Dataset Integration (DADI), which replaces the electronic Application Form (eAF)
According to various sources the idiom “Tongue-in-Cheek” refers to a “humorous or sarcastic statement expressed in a mock serious manner.” The physical act of putting your tongue in your cheek once meant contempt – or in the ironic usage of the term – to put your tongue in your cheek to prevent laughter.
Critical design parameters of equipment and operational handling procedures in ocean transportation have a major impact to the airflow and temperature distribution within temperature-controlled ocean containers.
Collection of good quality data from clinical trials is essential to data analysis in order to produce robust results that meet the precise requirements for regulatory need. Data from clinical trials is increasingly complex in nature, related to involved protocols, geography of trial sites, increasing data streams and technological advances.
This quarterly review on new drug applications (NDAs) contains data for applications approved during the first quarter of 2022. A total of 32 applications were approved by the FDA during these three months.