1. Forms & Submission Requirements
- Access required forms for NDA, ANDA, BLA, sNDA, IND, and orphan drug designations.
- Includes eCTD submission process and electronic gateway details.
- Step-by-step guidelines for submitting drug applications electronically.
2. Guidances (Drugs)
- Comprehensive database of FDA guidance documents for drug development, labeling, safety, and clinical studies.
- International harmonization standards for clinical trials, quality assurance, and pharmacovigilance.
3. Clinical Trials & Human Subject Protectio
- Regulations for Good Clinical Practice (GCP), informed consent, and investigator responsibilities.
- Database of ongoing and completed clinical trials in the U.S.
- Submission requirements for starting a clinical trial in the U.S..
4. CDER Small Business & Industry Assistance (SBIA)
- Support for small pharmaceutical companies & biotech firms.
- Free webinars and training materials for industry professionals.
CDER Small Business & Industry Assistance (SBIA)
5. Regulatory Information
- Legal framework covering drug approval, labeling, marketing, and post-market surveillance.
- Official list of approved generic and brand-name drugs.
- Database of FDA-licensed biologics and biosimilars.
6. Surveillance: Post Drug-Approval Activities
- FDA’s system for monitoring drug safety after approval.
- Report and track adverse drug events and product problems.
- Special safety programs for high-risk drugs.
Surveillance: Post Drug-Approval Activities
7. CDERLearn Training and Education
- Free self-paced educational courses on FDA drug regulation.
- On-demand training for industry professionals and healthcare providers.