USFDA definition
Examples of USFDA in a sentence
Tenth Licenses / Certificates as per US-FDA / European CE / Equivalent Indian Standards (wherever applicable).
Tunnelled Cuffed Double Lumen Chronic Dialysis Catheter: straight(adult) USFDA / European CE/ Approved / Equivalent Indian Standard Approved Sterile pack Biocompatible Sterile Kink resistant Material should be biocompatible, Complete sterile pack including complete kit.
USFDA / European CE/ Approved / Equivalent Indian Standard Approved The certificate should be attached.
While in the possession or control of Pfizer, Records will be available at reasonable times for inspection, examination and copying by USFDA and Customer.
PFIZER HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF ANY PRODUCT USING THE API BULK DRUG SUBSTANCE WILL BE SUCCESSFUL OR THAT THE API BULK DRUG SUBSTANCE WILL BE ACCEPTABLE TO, OR SUITABLE FOR USE IN PRODUCING A PRODUCT ACCEPTABLE TO, USFDA FOR SUBMISSION APPROVAL PURPOSES.
Coated with silver ion based antimicrobial agent.(silver sulphadiazine and chlorhexidine) USFDA / European CE/ Approved / Equivalent Indian Standard Approved The certificate should be attached.
In the event the United States Food and Drug Administration (USFDA) or any other governmental heath authority (HA) requires modifications to the PNT controller and/or ring in order to allow continuing sale within the Territory which would lead to an increase in the manufacturing costs to CI of more than 10%, the Parties agree to negotiate a new supply price.
If the foregoing discussions do not resolve the disagreement in a reasonable time (which will not exceed [***], a sample of Pfizer’s USFDA retained sample and a sample of the API Bulk Drug Substance in question will be submitted for retesting by Pfizer and Customer on a side-by-side basis for final determination of whether such API Bulk Drug Substance conforms to the Specifications.
Tunneled Cuffed Double Lumen Chronic Dialysis Catheter: curved(adult) USFDA / European CE/ Approved / Equivalent Indian Standard Approved Sterile pack Biocompatible Sterile Kink resistant Material should be biocompatible, Complete sterile pack including complete kit.
All Products sold by Distributor shall have Lot Number and Serial Number records as established by Distributor’s Regulatory and/or Quality Assurance departments and Distributor shall maintain these records so that each and every Product, up to and including when the Product is used or implanted, can be tracked in accordance with the USFDA tracking requirements then in effect.