article thumbnail

Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

article thumbnail

How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

Appropriate: Guarantees that DSIs are suitable for the contexts and populations in which they are used, adhering to relevant clinical and ethical standards. In a recent blog post, the FTC illustrated how an AI company’s TOUs and PPs might lead to enforcement action. Pro Tip: We are in a moment of transition.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data.

article thumbnail

Generative AI: Healthcare Innovations and Legal Challenges

Nixon Gwilt Law

As we explore each area, you'll find out how these AI applications can impact the company you’re building and the potential legal and ethical hurdles you might face. Synthetic data can: Address the scarcity of quality data due to the sensitive nature of health records, issues related to consent, and legal and ethical restrictions.

article thumbnail

The Future of Medical Sales Careers: Trends, Challenges, and Opportunities

Rep-Lite

In recent years, shifts in healthcare regulations, including updates in FDA guidelines and compliance standards, have significantly impacted sales representatives and healthcare providers alike. Don’t get it wrong, these are all aimed at ensuring patient safety, transparency, and ethical standards.

article thumbnail

How clinical outcome assessments can help us understand the patient experience

Clarivate

More recently, the FDA has developed the Patient Focused Drug Development (PFDD) Guidance Series, which provides sponsors with guidance on how to collect and submit patient experience data in medical product development for regulatory decision making. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

article thumbnail

Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59