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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.

21. Health document submission requirements for tobacco products: (revised)

Publication:

Silver Spring, MD : Center for Tobacco Products, October 2017

Subject(s):

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

22. E18 genomic sampling and management of genomic data

Publication:

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

Subject(s):

Data Collection -- standards
Genomics -- standards
Specimen Handling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

23. Listing of ingredients in tobacco products: (revised)

Publication:

Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, April 2018

Subject(s):

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

24. Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders

Publication:

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

Subject(s):

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

25. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018

Subject(s):

Logical Observation Identifiers Names and Codes
Electronic Health Records
Health Information Interoperability
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

26. Complicated urinary tract infections: developing drugs for treatment

Publication:

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

Subject(s):

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

27. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

Publication:

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

Subject(s):

Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

28. Medical product communications that are consistent with the FDA-required labeling: questions and answers

Publication:

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

Subject(s):

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

29. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:

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

Subject(s):

Drugs, Generic -- standards
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

30. Use of electronic health record data in clinical investigations

Publication:

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

Subject(s):

Clinical Trials as Topic
Electronic Health Records -- statistics & numerical data
Health Information Interoperability
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

31. Quality attribute considerations for chewable tablets

Publication:

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

Subject(s):

Chemistry, Pharmaceutical
Drug Liberation
Mastication
Quality Control
Solubility
Tablets -- pharmacokinetics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

32. Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations

Publication:

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

Subject(s):

Drug Evaluation, Preclinical
Radiopharmaceuticals -- administration & dosage
Radiopharmaceuticals -- pharmacokinetics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

33. E17 general principles for planning and design of multiregional clinical trials

Publication:

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

Subject(s):

Clinical Trials as Topic
Drug Evaluation
Research Design
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

34. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:

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

Subject(s):

Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

35. 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

36. Physiologically based pharmacokinetic analyses--format and content

Publication:

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

Subject(s):

Drug Evaluation, Preclinical
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

37. Allergic rhinitis: developing drug products for treatment

Publication:

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

Subject(s):

Drug Evaluation
Rhinitis, Allergic -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

38. Japanese medical equipment

Publication:

[Tokyo?] : Medical Analysis Section, 5250th Technical Intelligence Company, -18 March 1946

Subject(s):

Military Medicine -- instrumentation
Medicine Chests
Japan
Japan. Rikugun

39. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018

Subject(s):

Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

40. Migraine: developing drugs for acute treatment

Publication:

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

Subject(s):

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

41. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018

Subject(s):

Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

42. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers

Publication:

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

Subject(s):

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

43. Regulatory classification of pharmaceutical co-crystals

Publication:

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

Subject(s):

Chemistry, Pharmaceutical -- classification
Chemistry, Pharmaceutical -- standards
Crystallization -- classification
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

44. Assessing user fees under the Prescription Drug User Fee Amendments of 2017

Publication:

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

Subject(s):

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

45. How to prepare a pre-request for designation (pre-RFD)

Publication:

[Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018

Subject(s):

Equipment and Supplies -- classification
Drugs, Investigational -- classification
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

46. Resident training program of the medical service, Brooke General Hospital: lectures, seminars, and diagnostic conferences

Author(s):

Brooke General Hospital, author.

Publication:

[Fort Sam Houston, Texas] : Brooke General Hospital, [1947- ]

Subject(s):

Hospitals, Military
Internship and Residency
Texas
Brooke General Hospital.

47. Health and safety code

Author(s):

California, enacting jurisdiction.

Publication:

Sacramento, California : Supervisor of Documents

Subject(s):

Public Health -- legislation & jurisprudence
California

48. Medic's

Author(s):

Station Hospital (Hendricks Field, Fla.) author.

Publication:

Sebring, Florida : Station Hospital, Hendricks Field, 1943-[1944?]

Subject(s):

Hospitals, Military
Military Medicine
Florida
Station Hospital (Hendricks Field, Fla.)

49. Handbook of practical medicine

Author(s):

Eichhorst, Hermann, 1849-1921

Publication:

New York : Wood, 1886

Subject(s):

Clinical Medicine

50. Handbook of practical medicine (Volume 1)

Author(s):

Eichhorst, Hermann, 1849-1921

Publication:

New York : Wood, 1886

Subject(s):

Clinical Medicine