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1. The tropics: their resources, people, and future : a description of the tropical lands of Africa, Asia, Central and South America, Australasia and the Pacific; their natural products, scenery, inhabitants and industries, and the possibilities of their future development

Author(s):

Enock, C. Reginald (Charles Reginald), 1868-1970 author

Publication:

New York : Charles Scribner's Sons, 1915

Subject(s):

Geography
Tropical Climate

2. 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

3. Enforcement policy--OTC sunscreen drug products marketed without an approved application

Publication:

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

Subject(s):

Health Policy
Marketing
Sunscreening Agents
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Acne vulgaris: establishing effectiveness of drugs intended for treatment

Publication:

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

Subject(s):

Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:

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

Subject(s):

Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Complicated intra-abdominal infections: developing drugs for treatment

Publication:

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

Subject(s):

Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

Publication:

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

Subject(s):

Carcinogenicity Tests -- standards
Carcinogens
Chemistry, Pharmaceutical
DNA Damage -- genetics
Drug Contamination -- prevention & control
Mutagenicity Tests -- standards
Mutagens
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Bioanalytical method validation

Publication:

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

Subject(s):

Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Assessing user fees under the biosimilar user fee amendments of 2017

Publication:

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

Subject(s):

Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)

Publication:

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

Subject(s):

Product Labeling -- standards
Tobacco Products -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

11. Elemental impurities in drug products

Publication:

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

Subject(s):

Chemistry, Pharmaceutical
Drug Contamination
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

12. Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances

Publication:

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

Subject(s):

Chemistry, Pharmaceutical
Drug Liberation
Solubility
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

13. Threshold

Publication:

[New York, N.Y.] : Audio Productions, [1969]

Subject(s):

Anesthesiology
Biomedical Research
Pain Threshold
Pain Management

14. Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:

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

Subject(s):

Drug Compounding -- standards
Drug Industry -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

15. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018

Subject(s):

Genetic Testing
Germ-Line Mutation
Diagnostic Test Approval
Reagent Kits, Diagnostic -- standards
Sequence Analysis, DNA
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

16. Clinical trial imaging endpoint process standards

Publication:

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

Subject(s):

Clinical Trials as Topic -- standards
Diagnostic Imaging -- standards
Endpoint Determination -- standards
Research Design -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

17. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, July 2018

Subject(s):

Blood Component Transfusion
Blood Safety -- standards
Blood Transfusion
Zika Virus Infection -- blood
Zika Virus Infection -- transmission
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

18. Labeling for biosimilar products

Publication:

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

Subject(s):

Biosimilar Pharmaceuticals
Drug Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

19. Nonallergic rhinitis: developing drug products for treatment

Publication:

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

Subject(s):

Clinical Trials as Topic
Drug Evaluation
Rhinitis -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

20. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)

Publication:

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

Subject(s):

Registries -- standards
Tobacco Products -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.