FDCA definition: Copy, customize, and use instantly
Introduction
The term "FDCA" refers to the Federal Food, Drug, and Cosmetic Act, a U.S. law that regulates food safety, drugs, medical devices, and cosmetics. It establishes requirements for labeling, approval, and enforcement to protect public health.
Below are various examples of how "FDCA" can be defined in different contexts. Copy the one that fits your needs, customize it, and use it in your contract.
Definition of "FDCA" as federal regulatory law
This definition ties "FDCA" to its role as a governing law for food, drugs, and cosmetics.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, as codified in Title 21 of the United States Code, and all rules and regulations promulgated thereunder.
Definition of "FDCA" as regulatory framework for pharmaceuticals
This definition connects "FDCA" to pharmaceutical approvals and compliance.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, including any amendments, which governs the approval, manufacturing, and marketing of pharmaceutical products in the United States.
Definition of "FDCA" as food safety legislation
This definition links "FDCA" to food safety requirements and regulatory oversight.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, ensuring food safety through regulations on adulteration, misbranding, and contamination, as enforced by the FDA.
Definition of "FDCA" as medical device regulation
This definition applies "FDCA" to medical device approvals and compliance.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, setting forth the regulatory framework for medical devices, including classification, premarket approval, and post-market surveillance.
Definition of "FDCA" as cosmetics regulation
This definition addresses "FDCA" as the primary law governing cosmetic product safety.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, providing regulations for cosmetic products, including labeling, misbranding, and product safety requirements.
Definition of "FDCA" as enforcement authority for the FDA
This definition highlights "FDCA" as the statutory basis for FDA enforcement actions.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, granting the FDA authority to enforce compliance through warnings, recalls, and penalties for violations.
Definition of "FDCA" as labeling and marketing law
This definition emphasizes "FDCA" as the governing law for product labeling and advertising.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, regulating the labeling, marketing, and advertising of food, drug, and cosmetic products to prevent misleading claims.
Definition of "FDCA" as approval process for new drugs
This definition ties "FDCA" to the drug approval and clinical trial process.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, which establishes the requirements for preclinical testing, clinical trials, and new drug applications for FDA approval.
Definition of "FDCA" as control over controlled substances
This definition applies "FDCA" to drug scheduling and controlled substance regulations.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, outlining regulations for controlled substances, including classification, distribution, and prescription requirements.
Definition of "FDCA" as dietary supplement regulation
This definition connects "FDCA" to dietary supplement safety and claims.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, setting forth requirements for dietary supplement labeling, ingredient disclosures, and structure/function claims.
Definition of "FDCA" as animal drug regulation
This definition links "FDCA" to veterinary drug approvals.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, regulating the safety, efficacy, and marketing of veterinary pharmaceuticals and animal feed additives.
Definition of "FDCA" as food additive safety regulation
This definition ties "FDCA" to food additive approval processes.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, ensuring the safety of food additives through premarket approval and risk assessments conducted by the FDA.
Definition of "FDCA" as prescription and OTC drug classification
This definition applies "FDCA" to drug categorization.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, establishing criteria for classifying drugs as prescription or over-the-counter based on safety and intended use.
Definition of "FDCA" as recall authority framework
This definition connects "FDCA" to product recalls and enforcement.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, granting the FDA authority to mandate recalls of unsafe or misbranded products.
Definition of "FDCA" as consumer protection law
This definition highlights "FDCA" as a consumer safety measure.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, enacted to protect consumers from unsafe, misbranded, or adulterated food, drugs, and cosmetics.
Definition of "FDCA" as penalty and enforcement guideline
This definition ties "FDCA" to legal penalties for noncompliance.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, establishing civil and criminal penalties for violations, including misbranding, adulteration, and noncompliance.
Definition of "FDCA" as import/export regulation for FDA products
This definition links "FDCA" to international trade regulations.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, setting forth import and export requirements for FDA-regulated products to ensure compliance with U.S. safety standards.
Definition of "FDCA" as medical device recall requirements
This definition applies "FDCA" to recall procedures.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, mandating recall procedures for defective or non-compliant medical devices to protect public health.
Definition of "FDCA" as generic drug regulation
This definition ties "FDCA" to generic drug approval pathways.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, establishing the Abbreviated New Drug Application (ANDA) process for approving generic drugs.
Definition of "FDCA" as biologics regulation
This definition connects "FDCA" to biological product approvals.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, providing regulatory oversight for biologics, including vaccines, gene therapies, and biosimilars.
Definition of "FDCA" as orphan drug approval framework
This definition applies "FDCA" to orphan drug development.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, outlining special incentives and regulatory pathways for orphan drugs used to treat rare diseases.
Definition of "FDCA" as pediatric drug regulation
This definition ties "FDCA" to pediatric clinical trial requirements.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, mandating additional clinical studies and labeling requirements for pediatric drug use to ensure safety and efficacy.
Definition of "FDCA" as post-market drug surveillance framework
This definition connects "FDCA" to ongoing safety monitoring.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, establishing post-market surveillance programs to monitor adverse drug reactions and ensure continued safety compliance.
Definition of "FDCA" as new dietary ingredient approval requirement
This definition applies "FDCA" to novel ingredients in dietary supplements.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, requiring manufacturers to submit safety data for new dietary ingredients before market introduction.
Definition of "FDCA" as mandatory adverse event reporting framework
This definition links "FDCA" to industry reporting obligations.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, mandating the reporting of serious adverse events associated with food, drugs, and dietary supplements.
Definition of "FDCA" as homeopathic product regulation
This definition ties "FDCA" to homeopathic medicine oversight.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, governing the marketing and labeling of homeopathic drug products to ensure compliance with safety standards.
Definition of "FDCA" as approval framework for combination products
This definition connects "FDCA" to combination drug-device approvals.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, outlining requirements for combination products containing both drug and device components.
Definition of "FDCA" as antimicrobial resistance monitoring law
This definition applies "FDCA" to antimicrobial drug regulation.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, enforcing guidelines to track antimicrobial resistance and limit the overuse of antibiotics in humans and animals.
Definition of "FDCA" as emergency use authorization (EUA) authority
This definition ties "FDCA" to public health emergencies.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, granting the FDA authority to issue emergency use authorizations for unapproved medical products during public health crises.
Definition of "FDCA" as high-risk food safety program
This definition connects "FDCA" to high-risk food oversight.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, mandating enhanced tracking and safety measures for high-risk food products susceptible to contamination.
Definition of "FDCA" as cosmetics recall process
This definition applies "FDCA" to unsafe cosmetic products.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, allowing the FDA to recall cosmetics that contain harmful ingredients or pose a health risk.
Definition of "FDCA" as online pharmacy regulation
This definition ties "FDCA" to internet-based drug sales.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, establishing regulations for the online sale of prescription medications to prevent fraud and ensure consumer safety.
Definition of "FDCA" as medical food oversight law
This definition connects "FDCA" to specialized nutrition products.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, defining and regulating medical foods intended for dietary management of specific diseases.
Definition of "FDCA" as track-and-trace drug system law
This definition applies "FDCA" to supply chain security.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, requiring manufacturers to implement track-and-trace systems to prevent counterfeit drugs from entering the supply chain.
Definition of "FDCA" as sunscreen product regulation
This definition ties "FDCA" to sunscreen testing and labeling.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, mandating UV protection standards, SPF labeling, and ingredient safety for sunscreen products.
Definition of "FDCA" as alternative protein regulation
This definition connects "FDCA" to plant-based and lab-grown food safety.
"FDCA" means the Federal Food, Drug, and Cosmetic Act, overseeing the labeling, safety, and approval process for alternative proteins, including plant-based and cultured meat products.
Definition of "FDCA" as pharmaceutical advertising standard
This definition applies "FDCA" to direct-to-consumer drug promotions.
"FDCA" refers to the Federal Food, Drug, and Cosmetic Act, establishing rules for truthful advertising, risk disclosure, and marketing claims for prescription drugs.
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.