NLM Digital Collections


Search Constraints

Start Over You searched for: Subjects Investigational New Drug Application Remove constraint Subjects: Investigational New Drug Application
Number of results to display per page

Search Results

1. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications


2. 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


4. 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


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


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 Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters


10. Bioanalytical method validation