Most everyone is familiar with the Food and Drug Administration or FDA, but not many realize the true breadth of their scope. The primary focus of the department is to enforce the Federal Food, Drug and Cosmetic Act (FD&C). This means they are responsible for protecting public health through the control and regulation of food, over-the-counter pharmaceutical drugs, vaccines, animal food & feed and other related areas. What may come as a surprise is that most of the regulations enforced by the FDA are not directly related to food or drugs and their jurisdiction extends to many other things like lasers and cellphones.
Why Would You Deal With The FDA?
There may be many reasons as to why someone may deal with the FDA. Two possible scenarios in which someone may find themselves face to face with the FDA would be in court or making sure that their product, service or other business related goods are compliant with current FDA regulations related to the item. In some cases you may need to refer to information pertaining to drugs or medical devices from historical records in order to support a legal strategy or provide information that is unavailable on the FDA’s website.
Who Do I Call?
Navigating the complex regulations put forth by the FDA can be a daunting task which is why in almost every circumstance it is better left to an expert like Dr. Sharlin of Sharlin Consulting LLC. Dr. Joshua Sharlin, PH.D is a FDA Regulatory Expert Witness and FDA Compliance Consultant with 30 years of experience. With direct hands-on experience with the entire FDA lifecycle from initial strategy through final review and approval by the FDA as a former FDA Reviewer, you can rely on his knowledge in regards to providing FDA related regulatory guidance and support to attorneys in cases or delivery masterful testimony and dispositions as an expert witness.
Learn More About Dr. Joshua Sharlin of Sharlin Consulting LLC.
