FDA definition: Copy, customize, and use instantly
Introduction
The term "FDA" refers to the U.S. Food and Drug Administration, a federal agency under the Department of Health and Human Services responsible for regulating food, drugs, medical devices, cosmetics, and other products to ensure public safety and efficacy. The FDA plays a crucial role in approving new drugs, monitoring product safety, and enforcing regulations related to public health.
Below are various examples of how "FDA" can be defined in different contexts. Copy the one that fits your needs, customize it, and use it in your contract.
Definition of "FDA" in pharmaceutical agreements
This definition ties "FDA" to drug approval processes.
"FDA" refers to the United States Food and Drug Administration, the federal agency responsible for evaluating, approving, and regulating pharmaceutical products for safety, efficacy, and quality.
Definition of "FDA" in medical device contracts
This definition connects "FDA" to device regulations.
"FDA" means the U.S. Food and Drug Administration, the agency overseeing the approval, classification, and post-market surveillance of medical devices in the United States.
Definition of "FDA" in food industry agreements
This definition links "FDA" to food safety.
"FDA" includes the United States Food and Drug Administration, the authority responsible for ensuring the safety, labeling, and quality of food products sold in the United States.
Definition of "FDA" in clinical trial agreements
This definition applies "FDA" to research oversight.
"FDA" refers to the United States Food and Drug Administration, the regulatory body that monitors and approves clinical trial protocols and outcomes for investigational drugs and devices.
Definition of "FDA" in biologics licensing agreements
This definition ties "FDA" to biological products.
"FDA" refers to the United States Food and Drug Administration, the federal agency responsible for regulating the licensing, approval, and oversight of biologics, including vaccines, blood products, and gene therapies.
Definition of "FDA" in cosmetic product agreements
This definition connects "FDA" to cosmetic safety.
"FDA" means the United States Food and Drug Administration, the regulatory authority overseeing the safety, labeling, and marketing of cosmetic products sold in the United States.
Definition of "FDA" in dietary supplement contracts
This definition links "FDA" to supplement regulation.
"FDA" includes the United States Food and Drug Administration, which enforces standards for dietary supplements, including labeling, manufacturing practices, and claims of safety.
Definition of "FDA" in drug manufacturing agreements
This definition ties "FDA" to production compliance.
"FDA" refers to the United States Food and Drug Administration, which sets and enforces good manufacturing practices (GMP) for the production of pharmaceutical products.
Definition of "FDA" in tobacco product agreements
This definition connects "FDA" to tobacco regulation.
"FDA" means the United States Food and Drug Administration, the federal agency authorized to regulate the manufacturing, marketing, and distribution of tobacco products in the United States.
Definition of "FDA" in post-market surveillance contracts
This definition links "FDA" to safety monitoring.
"FDA" refers to the United States Food and Drug Administration, which oversees post-market surveillance activities to ensure the ongoing safety and effectiveness of drugs, devices, and other regulated products.
Definition of "FDA" in import-export agreements
This definition ties "FDA" to product entry requirements.
"FDA" includes the United States Food and Drug Administration, which enforces regulations and inspection protocols for the import and export of food, drugs, and medical devices to and from the United States.
Definition of "FDA" in investigational product agreements
This definition connects "FDA" to research authorizations.
"FDA" means the United States Food and Drug Administration, the agency that grants investigational new drug (IND) and investigational device exemption (IDE) approvals for research purposes.
Definition of "FDA" in animal health products
This definition links "FDA" to veterinary oversight.
"FDA" refers to the United States Food and Drug Administration, which regulates animal drugs, feeds, and veterinary devices under its Center for Veterinary Medicine (CVM).
Definition of "FDA" in recall management
This definition ties "FDA" to corrective actions.
"FDA" includes the United States Food and Drug Administration, which oversees recalls and corrective actions for unsafe or non-compliant products under its regulatory jurisdiction.
Definition of "FDA" in pharmaceutical marketing agreements
This definition connects "FDA" to promotional compliance.
"FDA" refers to the United States Food and Drug Administration, which regulates the advertising, labeling, and promotional materials of pharmaceutical products to ensure accuracy and compliance.
Definition of "FDA" in over-the-counter drug agreements
This definition links "FDA" to non-prescription medicines.
"FDA" means the United States Food and Drug Administration, which oversees the formulation, labeling, and approval of over-the-counter drugs for safety and effectiveness.
Definition of "FDA" in emergency use authorization agreements
This definition ties "FDA" to expedited approvals.
"FDA" refers to the United States Food and Drug Administration, the authority that grants emergency use authorizations (EUAs) for medical products during public health emergencies.
Definition of "FDA" in new drug applications (NDAs)
This definition connects "FDA" to drug approvals.
"FDA" includes the United States Food and Drug Administration, which reviews and approves new drug applications (NDAs) for pharmaceuticals intended for U.S. distribution.
Definition of "FDA" in compliance audits
This definition links "FDA" to regulatory inspections.
"FDA" refers to the United States Food and Drug Administration, which conducts compliance audits and inspections of manufacturing, labeling, and distribution facilities.
Definition of "FDA" in clinical trial monitoring
This definition ties "FDA" to research oversight.
"FDA" means the United States Food and Drug Administration, which ensures that clinical trials are conducted in accordance with good clinical practices (GCP) and ethical standards.
Definition of "FDA" in medical device classifications
This definition connects "FDA" to device risk categories.
"FDA" refers to the United States Food and Drug Administration, which classifies medical devices into risk categories and establishes corresponding regulatory requirements.
Definition of "FDA" in generic drug applications
This definition links "FDA" to generic approvals.
"FDA" means the United States Food and Drug Administration, which evaluates and approves abbreviated new drug applications (ANDAs) for generic pharmaceuticals.
Definition of "FDA" in food labeling agreements
This definition ties "FDA" to consumer information.
"FDA" includes the United States Food and Drug Administration, which enforces food labeling regulations to ensure accurate and truthful information is provided to consumers.
Definition of "FDA" in combination product agreements
This definition connects "FDA" to multi-component products.
"FDA" refers to the United States Food and Drug Administration, which regulates combination products, such as drug-device or biologic-device combinations, to ensure safety and compliance.
Definition of "FDA" in advanced therapy agreements
This definition ties "FDA" to innovative treatments.
"FDA" refers to the United States Food and Drug Administration, the federal agency responsible for regulating advanced therapies, such as cell and gene therapies, to ensure safety and efficacy.
Definition of "FDA" in expedited approval programs
This definition connects "FDA" to priority pathways.
"FDA" means the United States Food and Drug Administration, which oversees expedited approval programs, including priority review, fast track, and breakthrough therapy designations for qualifying products.
Definition of "FDA" in pediatric product development
This definition links "FDA" to child-focused treatments.
"FDA" includes the United States Food and Drug Administration, which enforces pediatric study requirements and incentives under laws such as the Best Pharmaceuticals for Children Act (BPCA).
Definition of "FDA" in combination vaccine approvals
This definition ties "FDA" to immunization products.
"FDA" refers to the United States Food and Drug Administration, which regulates and approves combination vaccines to ensure safety and immunogenicity for public use.
Definition of "FDA" in biosimilar licensing
This definition connects "FDA" to biologic alternatives.
"FDA" means the United States Food and Drug Administration, which oversees the approval and regulation of biosimilars under the Biologics Price Competition and Innovation Act (BPCIA).
Definition of "FDA" in controlled substance regulations
This definition links "FDA" to drug scheduling.
"FDA" includes the United States Food and Drug Administration, which collaborates with the Drug Enforcement Administration (DEA) to regulate controlled substances, ensuring proper classification and distribution.
Definition of "FDA" in veterinary biologics
This definition ties "FDA" to animal health.
"FDA" refers to the United States Food and Drug Administration, which regulates veterinary biologics, including vaccines and diagnostic products for animals, under the Center for Veterinary Medicine (CVM).
Definition of "FDA" in imported food safety
This definition connects "FDA" to global food systems.
"FDA" means the United States Food and Drug Administration, which enforces safety standards and inspection protocols for imported food products entering the U.S. market.
Definition of "FDA" in orphan drug applications
This definition links "FDA" to rare disease treatments.
"FDA" includes the United States Food and Drug Administration, which administers the Orphan Drug Designation Program to incentivize the development of treatments for rare conditions.
Definition of "FDA" in post-approval commitments
This definition ties "FDA" to ongoing monitoring.
"FDA" refers to the United States Food and Drug Administration, which requires and oversees post-approval commitments, such as additional studies or safety monitoring, for approved drugs and devices.
Definition of "FDA" in food additive approvals
This definition connects "FDA" to ingredient safety.
"FDA" means the United States Food and Drug Administration, which evaluates and approves food additives to ensure they meet safety standards before being marketed for human consumption.
Definition of "FDA" in regenerative medicine
This definition links "FDA" to innovative therapies.
"FDA" includes the United States Food and Drug Administration, which regulates regenerative medicine products, including stem cell therapies, under the 21st Century Cures Act.
Definition of "FDA" in premarket approval (PMA) applications
This definition ties "FDA" to medical device scrutiny.
"FDA" refers to the United States Food and Drug Administration, which evaluates premarket approval (PMA) applications for Class III medical devices to ensure safety and effectiveness.
Definition of "FDA" in dietary ingredient notifications
This definition connects "FDA" to supplement oversight.
"FDA" means the United States Food and Drug Administration, which reviews new dietary ingredient (NDI) notifications for dietary supplements to assess safety before market entry.
Definition of "FDA" in medical imaging technologies
This definition links "FDA" to diagnostic tools.
"FDA" includes the United States Food and Drug Administration, which regulates medical imaging technologies, such as MRI and CT scanners, to ensure compliance with performance and safety standards.
Definition of "FDA" in food defense plans
This definition ties "FDA" to security measures.
"FDA" refers to the United States Food and Drug Administration, which oversees the implementation of food defense plans to protect against intentional contamination of the food supply.
Definition of "FDA" in antimicrobial resistance monitoring
This definition connects "FDA" to public health initiatives.
"FDA" means the United States Food and Drug Administration, which collaborates with other agencies to monitor and combat antimicrobial resistance in human and veterinary medicine.
Definition of "FDA" in electronic submissions
This definition links "FDA" to regulatory efficiency.
"FDA" includes the United States Food and Drug Administration, which mandates electronic submissions of regulatory documents through platforms such as the Electronic Submissions Gateway (ESG).
Definition of "FDA" in cosmetics labeling
This definition ties "FDA" to consumer transparency.
"FDA" refers to the United States Food and Drug Administration, which enforces labeling requirements for cosmetics to ensure that claims are accurate and non-misleading.
Definition of "FDA" in inspection agreements
This definition connects "FDA" to facility audits.
"FDA" means the United States Food and Drug Administration, which conducts facility inspections to verify compliance with good manufacturing practices (GMP) and regulatory requirements.
This article contains general legal information and does not contain legal advice. Cobrief is not a law firm or a substitute for an attorney or law firm. The law is complex and changes often. For legal advice, please ask a lawyer.