U.S. Department of Health & Human Services

NLM Digital Collections

Search

Search Constraints

Start Over You searched for: Subjects United States. Food and Drug Administration. Remove constraint Subjects: United States. Food and Drug Administration. Subjects Investigational New Drug Application Remove constraint Subjects: Investigational New Drug Application Subjects Humans Remove constraint Subjects: Humans Genre Guideline Remove constraint Genre: Guideline Dates by Range 2000 and later Remove constraint Dates by Range: 2000 and later
Number of results to display per page

Search Results

2. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

nlm:nlmuid-101713206-pdf

4. Bioanalytical method validation

nlm:nlmuid-101734209-pdf

6. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

nlm:nlmuid-101712948-pdf

8. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

nlm:nlmuid-101719981-pdf

9. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

nlm:nlmuid-101713196-pdf