Investigational New Drugs definition

Investigational New Drugs means those substances that require approval by the
Sample 1Sample 2Sample 3
Investigational New Drugs means those substances that require approval by the U.S. Food and Drug Administration for trials with human subjects pursuant to 21 CFR 312 (2002).
Sample 1

Examples of Investigational New Drugs in a sentence

  • Expanded Availability of Investigational New Drugs Through a Parallel Track Mechanism for People With AIDS and other HIV-Related Diseases, 57 Fed.

  • Expanded Availability of Investigational New Drugs Through a Parallel Track Mechanism for People With AIDS and Other HIV-Related Diseases, 55 Fed.

  • Administration of Investigational New Drugs to Members of the Armed Forces.

  • All serious event reporting will adhere to 21 CFR 312.32 for Investigational New Drugs (IND) and to the Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE, dated December 2012.

  • According to FDA CFR 312.32(a), FDA Guidance “Safety Reporting Requirements for Investigational New Drugs (INDs) and Bioavailability/Bioequivalence (BA/BE) Studies” finalized December 2012, European Directives 2001/20/EC and CT-3 Guideline, suspected adverse reaction means any AE for which there is a reasonable possibility that the medicinal product caused the AE.

  • In 2013, when sponsorship of the U.S. Investigational New Drugs (“INDs”) for vernakalant (IV) and vernakalant (oral) and the NDA for vernakalant (IV) were transferred to us from Merck Sharp & Dohme (“MSD”), we initiated discussions with the FDA to determine the next steps for the development of vernakalant (IV) in the United States.

  • These basic criteria will be used as cornerstone to attempt to assess the Iraqi recent situations and to evaluate the Iraqi level of development in the LTA aspects.Throughout the country, Iraq is facing an overwhelming amount of conflicted situation and lack of administrative roles in land and property policies.

  • Examples include FDA requirements for the conduct of certain types of clinical research after the submission of applications for Investigational New Drugs (IND) and under the auspices of a Radioactive Drug Research Committee (21 CFR 361.1).

  • Drugs classified as Treatment Investigational New Drugs (IND) by the FDA and devices with the FDA Investigational Device Exemption (IDE), any device to which the FDA has limited access or otherwise limited approval, and any services involved in clinical trials are considered experimental/investigational.

  • FDA’s regulations for drug (including biologic) and device investigations have different requirements for the submission of informed consent materials in applications (see sections IV.D.1, Investigational New Drugs and Biologics, and IV.D.2, Investigational Medical Devices, below).

Related to Investigational New Drugs

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Animal means any nonhuman animate being endowed with the power of voluntary action.