Firms that innovate and manufacture prescription drugs with the authorization of the FDA under the New Drug Application (NDA) process.
Firms that produce bioequivalent replications of brand-name drugs in terms of dosage, safety, strength, route of administration, quality, performance and intended use with the authorization of the FDA under the Abbreviated New Drug Application (ANDA) process.
ACTIVE PHARMACEUTICAL INGREDIENTS
Substances used in the manufacturing of final drug products that provide a direct therapeutic effect in the management, treatment or prevention of disease.
The combining of drugs for specific patients with needs that can’t be met by commercially available medicines.
Appliances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions with the authorization of the FDA under the Investigational Device Exemption (IDE) or premarket notification (510k) process. Medical devices range from non-invasive to implantable products.
DRUG DISCOVERY & DEVELOPMENT
The process by which new candidate medications are discovered and studied prior to human testing.
Medicinal preparations made from living organisms that govern the rhythmic occurrence of certain biochemical, physiologic, and behavioral phenomena of the human genome with the authorization of the FDA under the Biologics License Application (BLA).
Substances prepared from the causative agent of a disease or a synthetic substitute that are used to stimulate the production of antibodies and provide immunity against one or several diseases with the authorization of the FDA under the BLA.
Includes vitamins, minerals, herbs, meal supplements, sports nutrition products, natural food supplements, and other related products used to boost the nutritional content of the diet. The FDA regulates the dietary supplement industry under the 1994 Dietary Supplement Health and Education Act and the New Dietary Ingredient (NDI) notification process. Dietary Supplements are also impacted by California Proposition 65 (The Safe Drinking Water and Toxic Enforcement Act, which enforces Dietary and Herbal companies to provide “clear and reasonable warning” on their labels). LSR offers standalone coverage for Proposition 65 exposure as well as sublimit coverage within our product liability policy.
HUMAN CLINICAL TRIALS
Research studies with human volunteer participants to evaluate one or more health-related interventions to determine efficacy of a novel compound or device. Human Clinical Trials are overseen by the FDA Center for Drug Evaluation and Research through the review and approval of the study protocols and informed consent documents.