Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 24
Book Description
Guidelines for Drug Master Files
Author: Guidelines for Drug Master File
Author: United States. Food and Drug Administration. Drug Master File CommitteePublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
Book Description
Guidelines for Drug Master File
Author: United States. Food and Drug Administration. Drug Master File CommitteePublisher:
ISBN:
Category : Pharmacy
Languages : en
Pages :
Book Description
Guidelines for Drug Master Files
Author: Guidelines for Drug Master Files
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
Guideline for Drug Master Files
Author: Draft Guideline for Drug Master Files
Author: Center for Drugs and Biologics (U.S.)Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 19
Book Description
Guideline for Drug Master File
Author: Draft Guideline for Drug Master Files
Author: United States Food and Drug AdministrationPublisher:
ISBN:
Category :
Languages : en
Pages : 29
Book Description
Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research
Author: Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) presents the full text of "Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research," published August 2001. The document represents the current thoughts of the FDA on submitting Type V Drug Master Files to the CBER. A drug master file is a submission of information to the FDA that may be used to provide information about facilities or processes used in the manufacturing, processing, packaging, and storing of human drugs and biological products. The document is available in PDF format.