The FDA has announced their FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA, please follow link for full information.
Please see the FDA webpage for updates on valsartan recalls.
Guidance Document updates on the FDA website:
All centers:
- Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
- Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
- Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
CDER:
- Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Q & A
- Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities
- Insanitary Conditions at Compounding Facilities
- Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities
- Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
- Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
- Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
- Testicular Toxicity: Evaluation During Drug Development
- M9 Biopharmaceutics Classification System-Based Biowaivers
CDER & CBER:
- Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications
- ANDA Submissions – Content and Format
- Adaptive Designs for Clinical Trials of Drugs and Biologics
- Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics
- Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs
- Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings
- Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
- Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
- Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements
- Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
CDRH:
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
- Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
- The Special 510(k) Program
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
CBER:
Remember to keep up with CDER Product – Specific Guidances for Generic Drug Development. October had 2 new guidances and 23 revisions.