The FDA issued warning letters to several CBD companies for selling unapproved products with unsubstantiated medical claims.
How can you ensure readiness and compliance for FDA inspections? It is important for companies to investigate who the FDA targets, and how, to make sure they follow regulations.
Companies must develop a plan to ensure that they are in compliance during inspections to ensure FDA readiness
Opening up lines of communication with the FDA can often be intimidating for companies, and the process does not seem straightforward. Fortunately, there are many ways of undertaking this process–whether it be because your company is finding ways to...
Not all products have to meet the U.S. Federal Drug Administration’s (FDA) approval: certain biologics and dietary supplements do not require it, and there are alternative pathways for OTC drugs and other products to skip the process.
Drugmakers have become increasingly entangled in kickback and bribery schemes, and as a consequence, face millions in settlement to the U.S. government.