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FDA Guidances

All Information was adapted from the Food and Drug Administration website as a service to our readers. The most current versions can be found on the FDA Website.
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1 FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies
2 Good Laboratory Practice for Nonclinical Laboratory Studies
3 Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination
4 CGMP for Phase 1 Investigational Drugs
5 Investigational New Drug Applications (INDs)— Determining Whether Human Research Studies Can Be Conducted Without an IND
6 FDA Residual Drug in Transdermal and Related Drug Delivery Systems
7 FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
8 Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived
9 Animal Models - Essential Elements to Address Efficacy Under the Animal Rule
10 Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration
11 Nonclinical Safety Evaluation of Pediatric Drug Products
12 Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
13 Photosafety Testing
14 Recommended Approaches to Integration of Genetic Toxicology Study Result
15 Redbook 2000
16 Reference Guide for the Nonclinical Toxicity Studies of Antiviral Drugs Indicated for the Treatment
17 S7B- SP QT Interval Prolongation by Human Pharmaceuticals
18 Safety Testing of Drug Metabolites
19 Single Dose Acute Toxicity Testing for Pharmaceuticals
20 Nonclinical Safety Evaluation of Drug or Biologic Combinations
21 Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmissio
22 Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals
23 Carcinogenicity Study Protocol Submissions:
24 Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
25 Content and Format of Investigational New Drug Apps (INDs) for Phase 1 Drugs
26 Developing Medical Imaging Drug and Biological Products, Part 1: Conducting Safety Assessments
27 Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healt
28 Exploratory IND Studies
29 Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application
30 Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches
31 Immunotoxicology Evaluation of Investigational New Drugs
32 Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicitie
33 Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals
 

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