FDA Center for Drug Evaluation and Research (CDER)
As part of the US Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The Center is a consumer watchdog in America's healthcare system. CDER's best-known job is to evaluate new drugs before they can be sold. The Center's review of new drug applications not only prevents quackery, but it provides doctors and patients with the information they need to use medicines wisely. The Center makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.
Getting Started with CDER
- Start Here! "Engaging with the FDA During New Drug Development" web-based training course
- Welcome to CDER SBIA Learn
- Web-based training course: Best Practices for Communication Between FDA and IND Sponsors During Drug Development
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry
Categories of Therapeutic Biological Products Transferred to CDER
- Monoclonal antibodies for in vivo use.
- Proteins intended for therapeutic use, including cytokines (e.g. interferons), enzymes (e.g. thrombolytics), and other novel proteins, except for those that are specifically assigned to CBER (e.g., vaccines and blood products). This category includes therapeutic proteins derived from plants, animals, or microorganisms, and recombinant versions of these products.
- Immunomodulators (non-vaccine and non-allergenic products intended to treat disease by inhibiting or modifying a pre-existing immune response).
- Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo.
Resources by Technology Category
The resources below are to connect entrepreneurs with a set of curated links available from the United States Food and Drug Administration (FDA) and contain links to resources that are relevant for early-stage companies developing oncology-related biological therapeutics.
I am working on an imaging drug – where can I get started?
- Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments
- Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications
- Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies
I am working on a radiation therapy – where can I get started?
- Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations
- Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations
- Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals
Orphan Drug/Rare Disease
I am working on an orphan drug/rare disease – where can I get started?
- CDER Rare Diseases Team
- Webinars on topics related to development of products intended to treat rare diseases
- Resources: Developing Products for Rare Diseases and Conditions
- Orphan Drug Designation Request Form and Related Webinar (drugs and biological products)
I am working on a drug/device combination or drug delivery product – where can I get started?
- Combination Products Contacts
- Request for Designation (RFD) Process to assign jurisdiction to for combination products
- Combination Products Guidance Documents
- Principles of Premarket Pathways for Combination Products
- Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
Companion Diagnostic Device
I am working on a companion diagnostic device where - can I get started?
- Overview: Companion Diagnostics
- In Vitro Companion Diagnostic Devices
- Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
I am working on a small molecule product - where can I get started?
- Overview and Differences in Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development
I am working on a biologic antibody product - where can I get started?
Premarket Submission Resources
What is the right premarket submission for my technology?
New Drug Application (NDA) Resources
Biologic License Application (BLA) Resources
- FAQs about Therapeutic Biological Products
- S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
- S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Expedited Review Programs
Investigational New Drug (IND) Resources
- Overview: Investigational New Drug (IND) Application
- “Introduction to Investigational New Drug Applications” and “Regulatory and Administrative Components of an IND Application”
Taped presentations from REdI Spring 2017 Conference (May 9, 2017 Drug Track)
- Resources: Investigator-Initiated Investigational New Drug (IND) Applications
- IND Forms and Instructions
- Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting