Search

1. Special protocol assessment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 2018

Subject(s):

Clinical Trials as Topic -- standards
Drug Approval
Drug Evaluation, Preclinical -- standards
Research Design
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:

Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018

Subject(s):

Drug Approval
Orphan Drug Production
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2017

Subject(s):

Documentation -- standards
Drug Approval
Canada
Europe
Japan
Switzerland
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, January 2018

Subject(s):

Biological Products
Drug Approval
Drug Packaging
Prescription Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Fraud fighters

Publication:

[Culver City, CA] : RKO Pathe, c1949

Subject(s):

Drug Approval
Fraud -- prevention & control
Advertising
Product Surveillance, Postmarketing
United States. Food and Drug Administration

6. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

Publication:

Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017

Subject(s):

Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
United States
United States. Department of Health and Human Services
United States. Department of Homeland Security
United States. Food and Drug Administration

7. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters

Publication:

Washington, D.C. : U.S. Government Accountability Office, January 2017

Subject(s):

Anti-Bacterial Agents -- therapeutic use
Drug Approval
Drug Industry
Drugs, Investigational
Investigational New Drug Application
United States
United States. Food and Drug Administration

10. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2017

Subject(s):

Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration