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
Many have been assigned blame for the nation’s prescription opioid epidemic--including clinicians, patients, and pharmaceutical distributors. This has shifted attention away from policymaker attempts to address the crisis.
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...
Setting up effective, compliant investigational drug pharmacies means reviewing FDA requirements and applicable state boards of pharmacy. Depending on the regulatory body reviewing the pharmacy, different parameters may need to be met. In this...