This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials.

The Drug Regulatory Authority of Pakistan (DRAP) has published guidance on the requirement for clinical trials or biosimilarity studies to support the registration of locally manufactured biological ...

Pharmaceutical industry groups, drugmakers, and other industry stakeholders are pressuring the US Food and Drug Administration (FDA) to finalize its proposed rule to update the format of the National ...

Pharmaceutical and medical device manufacturers should not assume that recent staff cuts at the US Food and Drug Administration (FDA) mean the agency will inspect less often and take fewer enforcement ...

BRUSSELS @ Experts from the European Commission shed light on the proposed wide-ranging changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) that have been put ...

The US Food and Drug Administration (FDA) has announced it will take a flexible approach to reviewing all new cell and gene therapy (CGTs) biologics license applications (BLAs) to expedite the ...

The US Food and Drug Administration (FDA) issued a draft guidance on Friday to assist sponsors in using Bayesian methods to support the safety and effectiveness of new drugs in clinical trials. These ...

The dietary supplement industry in the US faces increasing class action risk driven by labeling, testing, and compliance claims. Courts continue to apply the reasonable consumer standard when ...

Currently, the standards TGO 91 and TGO 92 establish the rules for the information that companies must include on the labels of prescription and over-the-counter (OTC) medicines, respectively. The TGA ...

The US Food and Drug Administration (FDA) on Thursday issued warning letters to 12 manufacturers and retailers for illegally marketing breast binders to children for gender-affirming surgery. The ...

Washington, DC @ Experts said that the US Food and Drug Administration (FDA) should provide more clarity on how it intends to regulate the use of artificial intelligence and large language models when ...

This two half-day virtual workshop offers foundational-to-intermediate training on US drug and biologic promotion rules, including FDA, FTC/NAD, digital media, enforcement, and PRC roles. Ideal for ...