Like any industry, recalls in the pharmaceutical industry are complex and expensive. However, as an added concern, pharmaceutical recalls have the potential to alter short and long-term health outcomes. Understanding the recall process for...
The United States Food and Drug Administration (FDA) approval process is complex and involves multiple people's input, opinions, and expertise, including the FDA advisory committees. Every time a new drug is approved, a recall is...
The United States Food and Drug Administration (FDA) is responsible for regulating everything from cosmetic products to medical devices to prescription drugs. In recent years, the FDA has been under enormous pressure to accelerate its...
The FDA approval process is complex and involves multiple steps. Understanding how a prescription drug becomes available over the counter (OTC) is essential for healthcare professionals, members of the pharmaceutical industry, and...
The FDA approval process is multi-faceted and involves several aspects. One of these aspects is accelerated approval, which is meant to approve drugs to treat severe or fatal diseases. According to a...
The FDA announced guidance Thursday that allows manufacturers and distributors of dietary supplements to submit late new dietary ingredient (NDI) notifications if they have failed to do so. Directors...
GW Pharmaceuticals announced last week that its cannabinoid (CBD) prescription medicines brought in total revenue of $109.1 million for the fourth quarter of 2019, and $311.3 million for the full...
Esperion recently announced that the FDA approved Nexletol an LDL-cholesterol lowering medicine, boosting access to medicine for patients with familial hypercholesterolemia or atherosclerotic...
Study sponsors will be subject to a new requirement for pediatric investigations beginning August 18, with new Food and Drug Administration draft guidance offering transitional information.
The...
A new study published Tuesday in JAMA suggests that the evolution of drugs and biologics’ regulatory approval programs at the US Food and Drug Administration has resulted in a system that...
