Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.
In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.
Practical next steps for pharmaceutical manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.
How are increased compliance requirements impacting medical devices? Discover the Future of Medical Device Regulation.We will dive into the rapid growth of the medical device sector, driven by cutting-edge technologies and rising regulatory requirements.
Watch our interactive discussion session focusing on the evolution and outlook of Fast Healthcare Interoperability Resources (FHIR).FHIR represents a significant step in how we manage and exchange information and is rapidly gaining acceptance. In this session, industry experts will provide an introduction to the FHIR initiative, explore some current applications as well as the impacts, benefits and prospective timelines.
As the world shifts towards electronically delivered e-Labeling, it's essential to stay ahead of the game. Regulatory Authorities are now permitting and encouraging online e-PIL content, with other regions follow suit.
The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case
It takes endurance and the tools of skilled professionals to advance a new product from R&D through to market. The investment is enormous, and the competition is breathing down the innovator's neck. Can you afford the costs of a recall or product delay?
AI is already being used in many Life Science applications, meanwhile Health Authorities are looking to regulate the use of AI. As a regulatory affair professional, it is essential to have an understanding of this technology. In this general introduction to the field of AI, different uses of the term "Artificial Intelligence" will be discussed, and which might be desirable in a given context.
Labeling compliance is important. Find out why, and discover how you can ensure your product labeling is compliant with regulations for pharmaceutical and food products.
