Search results
Results From The WOW.Com Content Network
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
Errors on the forms can cause delays or confiscation of the goods. For that reason, importers often use a customs brokerage to clear goods through customs. [4] Some nations require a customs declaration form from each person crossing the border, while other nations require one form per family traveling together.
Customs Manifest 310 Freight Receipt and Invoice (Ocean) 311 Canada Customs Information 312 Arrival Notice (Ocean) 313 Shipment Status Inquiry (Ocean) 315 Status Details (Ocean) 317 Delivery/Pickup Order 319 Terminal Information 322 Terminal Operations and Intermodal Ramp Activity 323 Vessel Schedule and Itinerary (Ocean) 324
(Reuters) -Abbott Laboratories said on Monday the U.S. health regulator had cleared the company's two new over-the-counter glucose monitoring devices, expanding its presence in a fast-growing ...
Customs broker is a profession which expertise include tariff and customs laws, rules and regulations for the clearance of imported or exported goods or merchandise from customs authority, preparation of import or export documents including computation and payment of duties, taxes and other charges accruing thereon, representing clients before ...
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...