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...
Recessions happen—that’s just the price of doing business in a capitalist system. The ability to predict when one will happen would obviously confer a lot of benefits to societies, businesses, and individuals. But foretelling the future is always a risky and uncertain proposition. As the old...
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...
Combination product information, if applicable Proposed meeting dates and times including when the requester is not available A list of proposed questions grouped by FDA discipline including a brief explanation of each question’s context and purpose ...
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.
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?
Instagram Shopping is directly linked to your Facebook Shop. To set up a shop, users must link their Instagram business account to their Facebook business profile. Once that’s completed, users can upload an existing product catalog or create a new one. Then you can use Instagram Product Tag...
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 ...