The Food and Drug Administration (FDA) has several regulations governing medical practices performed by health care providers. Unfortunately, many providers are unaware of how far reaching these are until the FDA initiates an investigation into their practice, because of an alleged violation of one or several FDA laws. When this happens, you need effective legal representation that will show you how to win an FDA investigation into your business.
Physicians, physical therapists, nurses, and other health care providers all have to adhere to FDA regulatory requirements. However, many find it difficult to keep apace of the changing regulations and statutes that affect matters such as compliance, reimbursement, and security. Hence some unintentionally become the subject of FDA investigations.
FDA investigations may center on any number issues with regards to FDA standards and regulations issues, including the ‘off-label’ use of drugs. This involves the use of medications for diseases or symptoms other than those approved by the FDA. Physicians make themselves vulnerable when they engage in off label drug use.
The FDA also carries out investigations into the use of medical devices, dialysis centers, and scientific research that use human research subjects.
Businesses faced with an FDA investigation require legal representation from attorneys that are experienced with a wide spectrum of health care issues. This will allow them to adopt a strategic, integrative approach so they can efficiently resolve the matter.
At Nelson Hardiman, Los Angeles, CA we are very knowledgeable about the healthcare industry, and this has been very beneficial to our clients. Not only can we help you win an FDA investigation into your business, we can also help you address compliance issues. Give us a call today at 310-203-2800 for an appointment.