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...
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...
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.
The US Food and Drug Administration (FDA) has announced new restrictions concerning the marketing of tobacco products such as e-cigarettes and vape pens in an effort to mitigate risks to public health.