While the designation for what constitutes a combination product is clearly defined by the FDA, industry continues to push the boundaries for disease treatment with new and innovative breakthrough drug therapies. As regulatory professionals, the challenge we face is to align these new therapies w...
down the heart rate and then FDA received reports with also not just to adenosine but to a lot of other drugs that are filled in these glass syringes to include like amiodarone which as you know is like a drug that you read in cardiology, when a drug push amiodarone, it slows down the...
What Is Generative AI (GenAI)? Generative AI (GAI) is the name given to a subset of AI machine learning technologies that have recently developed the ability to rapidly create content in response to text prompts, which can range from short and simple to very long and complex. Different gener...
If a face-to-face, teleconference or videoconference meeting is granted the FDA will provide the sponsor preliminary written responses no later than 5 days before the scheduled meeting. If the feedback is easily understood and the sponsor needs no additional clarification regarding their questions, ...
Satisfying– a key success factor is achieving customer satisfaction through the appropriate channel, which raises issues such as: is the site easy to use, does it perform adequately, what is the standard of associated customer service and how are physical products dispatched?
In this episode of Shopify Masters, you’ll learn how one entrepreneur discovered a business idea during a trip to South Korea, quickly launched and then went back to redesign the brand.
Direct marketing can be seen as a presentation of your company, product, or service to your target customers. It aims to find, reach and motivate customers to take action—by buying your product. Oftentimes, the call-to-action for the consumer is the buy or try your product or service, ...
This can also lead toreduced costs. Rather than invest in the equipment, training and more needed to manufacture the component or product, you can pay another company to do this for you at a cost that is likely less than it would be if you took on the full job. This helps you keep ...
Each new update is designed and developed by the Dynamics 365 team. Any new update is first validated by the feature team, then validated in combination with the full product. During this time, extensive testing is done on various test topologies. A compatibility checker also runs tests to ens...
Product Development Gap Analysis As a company manufactures new products, gap analysis can be performed to analyze where the product could fall short. This type of gap analysis is often associated with the development of software products or items that take so long to develop that market demand ma...