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USFDA

About of Service

  • Drug Regulation:

    • Approval and Monitoring: The FDA evaluates new drugs before they can be sold to ensure they are safe and effective. This includes prescription and over-the-counter medications.
    • Post-Market Surveillance: The FDA monitors drugs once they are on the market to identify any adverse effects that were not evident during initial testing.

  • Food Safety:

    • Regulation and Inspection: The FDA ensures the safety and proper labeling of food products, dietary supplements, and bottled water.
    • Preventing Contaminations: The FDA works to prevent foodborne illnesses by setting safety standards and conducting inspections of food production facilities.

  • Medical Devices:

    • Approval and Regulation: The FDA evaluates and approves medical devices, ensuring they meet safety and efficacy standards before they can be marketed.
    • Monitoring and Reporting: The FDA tracks adverse events and problems associated with medical devices.

  • Biological Products:

    • Vaccines and Blood Products: The FDA regulates vaccines, blood, and blood products, ensuring they are safe, pure, potent, and effective.
    • Gene Therapies: The FDA also oversees advanced therapies like gene therapy and tissue-engineered products.

  • Radiation-Emitting Products:

    • Safety Standards: The FDA sets standards for radiation-emitting products such as X-ray machines and microwave ovens.
    • Public Health Protection: The FDA ensures these products do not pose unnecessary risks to health.

    • Uses and Benefits
    • Regulation of Food and Dietary Supplements: Ensuring the safety, nutritional quality, and labeling of food products. Monitoring dietary supplements and ensuring they are not harmful.
    • Regulation of Drugs: Overseeing the approval and regulation of prescription and over-the-counter medications. Ensuring the efficacy and safety of drugs before they can be marketed.
    • Regulation of Biological Products: Supervising the approval and monitoring of biological products like vaccines, blood products, and gene therapies. Ensuring these products are safe, effective, and manufactured according to federal standards.
    • Medical Devices: Regulating medical devices ranging from simple items like bandages to complex technologies like pacemakers. Ensuring devices are safe and effective for their intended use.
    • Radiation-Emitting Products: Regulating products that emit radiation, such as X-ray machines, microwave ovens, and laser devices. Ensuring these products do not pose unnecessary risks to health.

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    Charges Structure & Our Scope of Work

    Additional Disclosure

    1. Clinical Trials and Studies: Detailed information about any clinical trials conducted to evaluate the safety and efficacy of drugs or medical devices. This includes protocols, results, adverse events, and compliance with Good Clinical Practice (GCP) guidelines.

    2. Quality Control and Manufacturing Practices: Documentation of manufacturing processes, quality control measures, and adherence to Current Good Manufacturing Practices (cGMP) or other applicable standards.

    3. Product Labeling and Advertising: Disclosures related to product labeling, advertising claims, and promotional materials to ensure compliance with FDA regulations regarding accuracy and fair representation.

    4. Post-Market Surveillance: Reporting of adverse events, product defects, recalls, and other safety issues through the FDA's Adverse Event Reporting System (FAERS) or other applicable systems.

    5. Financial Interests and Conflicts of Interest: Disclosure of financial interests, relationships with suppliers or distributors, and any potential conflicts of interest that could impact the integrity of regulatory submissions or compliance activities.

    6. Regulatory Filings and Submissions: Complete and accurate submission of regulatory filings, including New Drug Applications (NDAs), Biologics License Applications (BLAs), Premarket Approval (PMA) applications for medical devices, or other relevant submissions.

    7. Inspections and Audits: Cooperation with FDA inspections and audits of facilities, records, and processes to demonstrate compliance with regulatory requirements.

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    • United States Food and Drug Administration (USFDA)
    • Introduction
    • The United States Food and Drug Administration (USFDA) is a federal agency within the Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and tobacco products.
    • History
    • The FDA's origins date back to the early 20th century with the passage of the 1906 Pure Food and Drugs Act, which aimed to curb the sale of adulterated and misbranded food and drugs. Over the years, its role and authority have expanded through various legislative acts to address emerging public health challenges.
    • Key Legislative Acts

    • Pure Food and Drugs Act (1906): Laid the foundation for federal food and drug regulation.
    • Federal Food, Drug, and Cosmetic Act (1938): Expanded the FDA's authority, requiring proof of safety for new drugs.
    • Drug Amendments (1962): Mandated proof of efficacy and safety before marketing drugs.
    • Medical Device Amendments (1976): Gave the FDA authority to regulate medical devices.
    • Food Safety Modernization Act (2011): Enhanced the FDA's ability to oversee food safety and prevent foodborne illnesses.
    • Mission
    • The FDA's mission is to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; ensuring the safety of the food supply, cosmetics, and radiation-emitting products; and regulating tobacco products. The FDA also advances public health by fostering innovations that make medicines and foods more effective, safer, and more affordable.
    • Responsibilities
    • The FDA's responsibilities are extensive and cover several key areas:
    • Food Safety
    • Regulation and Inspection: Ensuring the safety and proper labeling of food products, dietary supplements, and bottled water.
    • Preventing Contaminations: Setting safety standards and conducting inspections of food production facilities to prevent foodborne illnesses.
    • Drug Regulation
    • Approval and Monitoring: Evaluating new drugs for safety and efficacy before they can be marketed.
    • Post-Market Surveillance: Monitoring drugs on the market to identify any adverse effects not evident during initial testing.
    • Medical Devices
    • Approval and Regulation: Ensuring medical devices meet safety and efficacy standards before they can be marketed.
    • Monitoring and Reporting: Tracking adverse events and problems associated with medical devices.
    • Biological Products
    • Vaccines and Blood Products: Regulating vaccines, blood, and blood products to ensure they are safe, pure, potent, and effective.
    • Gene Therapies: Overseeing advanced therapies like gene therapy and tissue-engineered products.
    • Radiation-Emitting Products
    • Safety Standards: Setting standards for products that emit radiation, such as X-ray machines and microwave ovens.
    • Public Health Protection: Ensuring these products do not pose unnecessary health risks.
    • Cosmetics
    • Safety and Labeling: Overseeing the safety and labeling of cosmetics to ensure they are not adulterated or misbranded.
    • Veterinary Products
    • Animal Drugs and Feeds: Regulating the safety and efficacy of drugs and feeds for pets and food-producing animals.
    • Animal Health: Ensuring veterinary products are safe for animals and, if they are for food-producing animals, for human consumption as well.
    • Tobacco Regulation
    • Manufacturing and Marketing: Regulating the manufacturing, distribution, and marketing of tobacco products.
    • Public Health Initiatives: Reducing the health impact of tobacco use.
    • Organizational Structure
    • The FDA is led by the Commissioner of Food and Drugs, who is appointed by the President and confirmed by the Senate. The FDA comprises several centers and offices, each responsible for specific regulatory areas:
    • Center for Drug Evaluation and Research (CDER): Oversees the approval and monitoring of drugs.
    • Center for Biologics Evaluation and Research (CBER): Regulates biological products including vaccines and blood products.
    • Center for Devices and Radiological Health (CDRH): Regulates medical devices and radiation-emitting products.
    • Center for Food Safety and Applied Nutrition (CFSAN): Oversees food safety and nutritional quality.
    • Center for Tobacco Products (CTP): Regulates tobacco products.
    • Center for Veterinary Medicine (CVM): Oversees animal drugs and feeds.
    • Office of Regulatory Affairs (ORA): Manages field operations including inspections and enforcement.
    • Global Role and Influence
    • The FDA collaborates with international regulatory counterparts to ensure the global supply chain's safety and efficacy. It participates in international harmonization efforts and global health initiatives, extending its influence beyond the United States.
    • Public Engagement and Transparency
    • The FDA is committed to transparency and public engagement, providing a wealth of information through its website. This includes drug safety communications, food recalls, and consumer updates. The agency engages with stakeholders, including patients, healthcare providers, and industry representatives, to gather input and feedback on regulatory matters.

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    OUR REVIEW

    FAQ'S

    What is the FDA?

    The FDA (Food and Drug Administration) is a federal agency of the United States Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation.

    What does the FDA regulate?

    The FDA regulates a wide range of products, including: Prescription and over-the-counter pharmaceuticals Biologics (e.g., vaccines, blood products) Medical devices Food (excluding meat and poultry) Cosmetics Tobacco products Veterinary products Products that emit radiation (e.g., X-ray machines, microwave ovens)

    How does the FDA approve new drugs?

    The FDA approves new drugs through a rigorous process that includes: Preclinical testing (laboratory and animal studies) Investigational New Drug (IND) application Clinical trials (Phases 1, 2, and 3) New Drug Application (NDA) submission FDA review and decision

    What is the difference between FDA approval and FDA clearance?

    FDA Approval: This typically applies to drugs and high-risk medical devices. It means the product has been tested and reviewed for safety, efficacy, and quality. FDA Clearance: This generally applies to moderate-risk medical devices. It means the device is substantially equivalent to a legally marketed device.

    How does the FDA ensure the safety of the food supply?

    The FDA ensures food safety through: Setting and enforcing food safety standards Conducting inspections of food manufacturing and processing facilities Monitoring food imports Investigating foodborne illness outbreaks Educating consumers and industry on food safety practices