- 産業: Government
- Number of terms: 2516
- Number of blossaries: 0
- Company Profile:
The FDA is responsible for pprotecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the US food supply, cosmetics, dietary supplements, and products that give off radiation.
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
Industry:Life Sciences
Confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.
Industry:Life Sciences
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
Industry:Life Sciences
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
Industry:Life Sciences
An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.
Industry:Life Sciences
A generally available software component for which the user can not claim complete software life cycle control.
Industry:Life Sciences
A software verification and validation task to determine the extent of verification and validation analysis and testing that must be repeated when changes are made to any previously examined software products.
Industry:Life Sciences
The ability of a system or component to perform its required functions under stated conditions for a specified period of time.
Industry:Life Sciences
Un'abbreviato nuova applicazione della droga (ANDA) contiene dati che, quando inserita al centro della FDA per la valutazione della droga e della ricerca, ufficio di farmaci generici, fornisce per la revisione e l'approvazione finale di un prodotto di farmaci generici. Farmaco generico applicazioni sono chiamate "abbreviate", perché in genere non devono includere studi preclinici (animale) e dati clinici (umani) per stabilire la sicurezza e l'efficacia. , Invece, un generico ricorrente deve dimostrare scientificamente che il suo prodotto è bioequivalente (cioè, esegue nello stesso modo come il farmaco innovatore). Una volta approvato, il richiedente può produrre e commercializzare il prodotto farmaco generico per fornire un'alternativa sicura, efficace, di basso costo al pubblico americano.
Industry:Pharmaceutical
Questo numero della sei-cifra viene assegnato dal personale della FDA per ogni richiesta di autorizzazione commercializzare un farmaco generico negli Stati Uniti.
Industry:Pharmaceutical
