Biological products

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Biological products by Mind Map: Biological products

1. Laws, Regulation, Guidance and Other information

1.1. Guidance

1.1.1. Biologics General biologics guidances Allerginics Blood Cellular and Gene therapy Tissue Vaccine and related biological product Xenotransplantation Guidance agenda : guidance documents is planning to publish Regen Biologics

1.1.2. General Advisory committee Clinical trials Combination products General and cross-cutting topics Import and Export International council for Harmonization efficacy Joint safety/Efficacy quailty safety Veterinary International Conference on Harmonization

1.1.3. Other topic area guidances animal & veterinary combination products cosmetics drugs food medical devices radiation-emitting products

1.1.4. Related links

1.2. Procedure

1.3. Rules

1.4. Information on Biosimilars

1.5. Act

2. Establishment Registration

2.1. Blood establishment registration and product listing

2.2. Tissue establishment registration

3. Product Development

3.1. FAQ about minimally manipulated, Unrelated Cord Blood Products for Clinical Use

3.2. IND or Device exemption process (CBER)

3.3. Clinical Investigation Information

4. Product Application and Approval

4.1. Biologics License Applications (BLA) Process (CBER)

4.2. Premarket Approval (PMA) Process

4.3. New Drug Application (NDA) Process

4.4. 510(k) Process

4.5. Advertising & Labeling (Biologics)

4.6. Manufacturers Assistance (CBER)

5. Postmarketing, Compliance and Enforcement

5.1. Biologics Post-Market Activities

5.2. Biologic Product Security

5.3. CBER-Regulated Products: Shortages and Discontinuations

5.4. Compliance Programs (CBER)

5.5. Impact of Severe Weather Conditions on Biological Products

5.6. Exporting CBER-Regulated Products

5.7. Lot Distribution Database (LDD)

5.8. Product Surveillance (CBER)

5.9. Recalls (Biologics)

5.10. Report a Problem to the Center for Biologics Evaluation & Research

5.11. Direct Recall Classification Program

5.12. Safety & Availability (Biologics)

5.13. Untitled Letters (CBER)

5.14. Unique Device Identification - UDI

6. Spotlight

6.1. CBER Key Staff Directory

7. Recall & Alerts

7.1. Recalls (Biologics)

7.2. CBER-Regulated Products: Shortage and Discontinuations

7.3. Report a Problem to the Center for Biologics Evaluation & Research

7.4. Direct Recall Classification Program

8. Approvals & Clearances

8.1. Biologics Products & Establishments