ForensisGroup FDA regulation expert witnesses have extensive experience tracking, controlling, summarizing, and reporting submissions to the FDA.
In addition to the regulation and administration of food and drug products in the U.S., the agency also is in charge of the regulation of medical devices, radiation-emitting products, cosmetics, and tobacco products, as well as all aspects of vaccines, blood, and biologics, and animal & veterinary issues. Many of our experts have years of experience in a variety of industries, such as the pharmaceutical industry dealing with federal regulations. Some are former officials for the Food and Drug Administration.
They have conducted drug reviews and clinical studies for FDA approval, analyzed drug activity in humans, conducted human risk assessments, and worked on generic drug eligibility and approval. They consult on issues related to development and marketing of pharmaceuticals, drug approvals, regulatory affairs, and administrative procedure.
Federal regulations are required or authorized by statute, and some of these address a specific problem or known health hazard. Others are administrative or procedural. ForensisGroup FDA regulation expert witnesses have been involved in every aspect of the agency.
ForensisGroup can provide you with the CVs and fee schedules of highly reputable FDA regulation experts. Your initial case consultations with select expert witnesses, prior to retention, are complimentary. Let us connect you with a rigorously vetted expert witness based on your specific requirements.