INDA means an investigational new drug application.
INDA means any Investigational New Drug Application in relation to a Product(s) filed by Lilly or its approved designee with the FDA or a similar application filed in another jurisdiction;
INDA means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
Examples of INDA in a sentence
This may be an NDA, INDA, IDE, PMA, ANDA, NADA, 510K or other appropriate reference to a filing with the US FDA.
THE FIRST SCHEDULE ABOVE REFERRED TO : (Description of the said Property/Premises) (PROPERTY OWNED BY LAND OWNER) ALL THAT the piece and parcel of revenue free land measuring about 10.43 Decimals (equivalent to 10.43 Dec X435.6 = 6K- 4 Ch- 44 Sq.ft.) be little more or less together with one storied brick built up building lying and situate in Mouza- INDA, Sub Registry Office – Khargapur, R.S. Dag No. 36/1655, 36/1656, L.R. Dag No. 182, 183, L.R. Khatian Nos.
More Definitions of INDA
INDA means any Investigational New Drug Application or similar application in relation to a Product(s) filed by Novartis or its approved designee with the relevant Health Authority;
INDA means any investigational new product application in relation to a Product or Compound.
INDA means an investigational new drug application also known as a “Notice of Claimed Investigational Exemption for a New Drug” filed with the FDA, as defined in 21 CFR Part 312 or any and all foreign equivalents such as but not limited to a “clinical trials exemption” in the United Kingdom.
INDA means an investigational new drug application filed with the FDA for authorization to commence human clinical trials, and its equivalent in other countries or regulatory jurisdictions in the Territory.
INDA has the meaning specified in SECTION 6.29(A).
INDA means an investigational new drug application also known as a “Notice of Claimed Investigational Exemption for a New Drug” or a therapeutic biologic application (“BLA”) filed with the FDA, as defined, respectively, in 21 CFR Part 312 and 21 CFR Part 600-680, or any and all foreign equivalents.