KFDA definition

KFDA means Korean Food and Drug Administration, or any successor agency thereto.
View Source
KFDA means Korean Food and Drug Administration;
View Source
KFDA means the Korea Food & Drug Administration and any successor thereto.
View Source

Examples of KFDA in a sentence

  • MacroGenics will transfer its responsibilities for interacting with the KFDA to Green Cross, but Green Cross shall attempt to include MacroGenics on any face-to-face meetings or teleconferences, if deemed necessary by Green Cross, and shall not commit to making any revisions to the Phase I Clinical Trial unless for an immediate safety issues, without prior agreement with MacroGenics.

  • Green Cross shall allow MacroGenics to review any written correspondence to the KFDA before it is sent to the KFDA.

  • MacroGenics shall be responsible for providing to Green Cross any revisions to the investigator’s brochure and CMC information required for KFDA submissions.

  • Following each communication (whether by phone or in person) with the KFDA regarding matters arising under this Agreement, Green Cross shall prepare a record of such meeting in accordance with its standard business practices (e.g., written minutes) and provide to MacroGenics a copy of such record.

  • Green Cross may request MacroGenics to participate in meetings with the KFDA if it is foreseeable that there may be discussions about the Product beyond the scope of Green Cross’ development of the Product in the Territory (e.g., CMC matters, data from clinical trials MacroGenics conducted).

  • Cross may submit such filing, submission or response to the KFDA at the same time as Green Cross submits the same to MacroGenics; provided that Green Cross uses Commercially Reasonable Efforts to obtain additional time.

  • Each Party agrees to promptly inform the other Party of all KFDA, FDA or other Regulatory Authority regulations, notices, circulars or warnings applicable to the Product of which it becomes aware.

  • Bukwang allows Eisai to cross-file in the business territory of the data filed in Korea with the KFDA (or FDA equivalent in other countries by Bukwang’s affiliate company) at no cost.

  • All Regulatory Filings filed by KDP in the Territory shall be in the name of and owned by KDP, except those facility descriptions equivalent to those customarily found in a KFDA application relating to manufacturing of the Product, which is owned by Can-F▇▇▇ or its designee.

  • To date, over 40 of the company’s products have passed certification by many regulatory agencies such as the FDA (U.S.), EDQM (EU), TGA (Australia) , and KFDA (Korea) and are sold to more than 30 countries worldwide.

Related to KFDA

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

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

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency or any successor entity thereto.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: