FDA Validation definition

FDA Validation means the written authorization of the United states Food and Drug Administration and of California Department of Health Services to carry out the manufacturing of medical devices products at the Facility.
Sample 1

Examples of FDA Validation in a sentence

  • FDA Validation 42 viruses have been classified by the National Institute of Allergy and Infectious Diseases as life threatening category A, B or C pathogen threats in the United States.

  • With this information from the regional head of FDA who is listed in the FDA Validation Report of April 5, 2010 as one of the members of the team that conducted the validation, the SIIB is led to belief that the said validation report was in fact manu- factured in Monrovia and no validation exercise was conducted by the FDA.

  • Bonus Material• Example risk management tool used in a validation example Peter Amanatides, Vice President, QA and QC,Noven Pharmaceuticals Inc sessıom ra ● Prepare for FDA Validation InspectionsI.

  • Definitely NO3/3/2020 TuesdayDesired Day of the Week Keeping Your Analytical Procedures in compliance with the FDA: Validation, Documentation, and ChangeProposal Title:Analytical laboratories play key roles in the pharmaceutical industry.

  • He indicated further that the reference made to a visitation to the area in the FDA Validation Report of April 5, 2010 was in fact awareness conducted by the FDA of the CRL and not a validation of visit of PUP lands as claimed in the validation report.

  • Introduction to 21 CFR Part 11 Training, Compass Enterprise Technologies Ltd, Dallas, TX, June 2001Regulated Industry FDA Validation Overview Training Class, Pfizer PGRD, La Jolla, CA March 2002 Introductory GMP Training, Pfizer PGRD Research Informatics, La Jolla, CA May 2003Software Validation Overview Training, Pfizer PGRD, Research Informatics, La Jolla, CA August 2003 Introduction to CFR Part 111, The Dietary Supplement CGMPs, Redwood City, CA October 2007 PUBLICATIONS: PAPERS 1.

Related to FDA Validation

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • orphan means a child who has no surviving parent caring for him or her;

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.