The FDA was put into place to ensure that public health remained protected by regulating the manufacturing, distribution and marketing of a wide range of products. This in turn means that it has a very broad mandate to inspect companies to make sure...
Promotional and advertising materials for pharmaceutical drugs and medical devices must comply with certain regulatory guidelines. If a product is illegally promoted for off-label use, companies could incur heavy fines and other penalties. It...
Clinical trials are observations or experiments performed in clinical research. The objective of clinical trials is to determine how new medical approaches may affect human participants, and whether the intervention being tested is safe and...
HealthTech is a fast-growing industry within healthcare. It deals with the use of digital products to improve the accessibility, cost and quality of patient care. HealthTech includes items such as monitoring tools for patients, administrative tools...
There are federal, state and local regulatory frameworks that guide the way companies and individuals in the life sciences function. It is important that professionals within the life sciences adhere to these regulations, and stay informed about...
Healthcare refers to the system of professionals and organizations dedicated to providing medical care to patients. Healthcare includes, but is not limited to, pharmacies, hospitals, physician offices, labs, health insurance companies and doctors.
Pharmacogenomics is the study of genes and how they impact drug response in certain individuals. This information allows physicians to customize treatment plans for their patients by taking into account a patient’s genetic unique background.
COVID-19 has reshaped the healthcare industry – increasing the need for telehealth services and decentralized clinical trials. As the number of coronavirus cases grow, the way we view medicine, doctors, hospitals and insurance plans has been...
Bioethics is the application of ethics to the field of life sciences and health—it determines what constitutes an ethical approach in the world of clinical trials and research on hot button issues like eugenics, gene-editing, and the right to die.
A general counsel is a company’s primary attorney or source of legal advice. A few of the responsibilities assigned to the general counsel include providing strategic legal advice to senior management, keeping informed about legal issues...
Health care fraud involves filing dishonest health care claims to gain a financial benefit. The possible consequences of committing this type of fraud include fines, incarceration and loss of the right to practice in the industry.
Pharmacy is the science of preparing, compounding and dispensing medical drugs. The scope of pharmacy includes services relating to healthcare, such as clinical services and providing drug information. Pharmacies are subject to a number of FDA...