|
Products
- Product Approval Information
- Product Manufacturers
- Product Labeling
- Adverse Event & Biological Product Deviation Reporting
- Blood Establishment Computer Software
- Counterfeit Initiative
- Enforcement Actions
- Export Certification
- HIV, HTLV & Hepatitis Tests
- Product Deviation Reports
- Postmarket Commitments
- Recalls and Withdrawals
- Safety Information
- User Fee Billable Products
Industry
- Action Plans
- Adverse Event Reporting
- Clinical Investigator Information
- Combination Products
- Counterfeit Initiative
- Device Application Submission
- Electronic Submissions
- Export Certification
- FAQs
- FDAMA (FDA Modernization Act)
- How to Submit an IND (Investigational New Drug Application)
- MDUFMA (Medical Device User Fee & Modernization Act)
- PDMA (Prescription Drug Marketing Act)
- PDUFA (Prescription Drug User Fee Act)
- Product Shortages
- Postmarket Commitments
- Publications
- Related References
- Small Business Information
- CBER SOPPS (Standard Operating Procedures and Policies)
Consumer / Healthcare Information
- Adverse Event Reporting
- Clinical Investigator Information
- Counterfeit Initiative
- Countering Bioterrorism
- FDA Patient Safety News
- Frequently Asked Questions
- Healthcare Letters
- NIH Clinical Trials Database
- NLM MEDLINEplus Health Information
- Product Approvals
- Product Labeling
- Product Shortages
- Recalls and Withdrawals
- Safety Information
- Violative Advertising & Promotional Labeling Letters
- Warning Letters
- FDA Consumer / Healthcare Information
- FDA Consumer Magazine
Reading Room (EFOIA)
- Approval Information
- Blood Memos
- Compliance Policy Guides
- Enforcement Actions
- FDA Modernization Act (FDAMA)
- Guidances
- Healthcare Letters
- Information Sheets
- Meeting Minutes
- Medical Device User Fee & Modernization Act (MDUFMA)
- Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters
- Prescription Drug User Fee Act (PDUFA)
- Presentations / Summaries
- Product Shortages
- Recalls & Withdrawals
- Rules
- Safety Information
- Talk Papers
- Violative Advertising & Promotional Labeling Letters
- Warning Letters
- Additional Documents Available From FDA
- Related Publications
Meetings and Workshops
- Advisory Committees
- Clinical Hold / Refusal to File Meetings
- FDAMA - Stakeholder
- Minutes/Transcripts
- Presentations / Summaries
- Workshops & Conferences
|
Blood
- Advisory Committees: Blood Products; Transmissible Spongiform Encephalopathies
- Blood Action Plan
- Blood Establishment Computer Software
- Blood Establishment Registration
- Exceptions & Alternative Procedures Under 21CFR640.120
- Frequently Asked Questions
- Hemochromatosis Variances
- HIV, HTLV and Hepatitis Tests
- NIH Human Embryonic Stem Cell Registry
- Publications (Guidances, Rules, Memoranda)
- Transfusion Related Acute Lung Injury (TRALI)
- Bovine Spongiform Encephalopathy (BSE)
- Mercury in Plasma-Derived Products
- Monkeypox Virus Infections and Blood Plasma Donors
- Options for Arm Prep
- Particulate Matter
Vaccines
- Advisory Committee - Vaccines and Related Biological Products
- Adverse Event Reporting System (VAERS)
- Anthrax
- Approval Process
- Bovine Spongiform Encephalopathy (BSE)
- Frequently Asked Questions
- Flu (Influenza) Vaccine
- Licensed Vaccines
- Publications / Transcripts
- Smallpox
- Thimerosal
Cellular & Gene Therapy
- Biological Response Modifiers Advisory Committee
- Cellular Therapy Potential Treatment for Heart Disease
- Cloning Technology
- Gene Therapy Patient Tracking System
- Human Gene Therapy and the Role of the FDA
- New Human Gene Transfer Research Data System
- Publications
- Recombinant DNA and Gene Transfer, Office of Biotechnology Activities, NIH
- Type I Diabetes / Pancreatic Islet Transplantation
- Warning Letters
- Xenotransplantation Action Plan
Tissue
- Meeting Information
- NIH Human Embryonic Stem Cell Registry
- Publications
- Tissue Action Plan
- Tissue Banks: Dangerrs of Tainted Tissue
- Tissue Registration
- Xenotransplantation Action Plan
Devices
- Device Action Plan
- Devices Regulated by CBER
- Medical Device User Fee & Modernization Act (MDUFMA)
- Publications
- Application Submission Information
- Blood Establishment Computer Software
- HIV, HTLV and Hepatitis Tests
Allergenics
- Allergenic Products Advisory Committee
- Publications
Research
- Investigators
- Research Projects Search
- Research Opportunities
|
