Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
Book Description
Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products
Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products
Author: Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application
Author: Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: Center for Drugs and Biologics (É.-U.)Publisher:
ISBN:
Category :
Languages : en
Pages : 60
Book Description
Guideline on General Principles of Process Validation
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Book Description
Draft Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 50
Book Description
Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics
Author: Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer ProtectionPublisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
Book Description
Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and MedicinePublisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483
Book Description
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.