Guidance Document updates on the FDA website
CDER
- Section 503A Bulks List Final Rule Questions and Answers
- Determining Whether to Submit an ANDA or a 505(b)(2) Application
- Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The – Counter Monograph: Study Elements and Considerations
- Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations
- Clinical Lactation Studies: Considerations for Study Design
- Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment
- Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes
- Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles
CDER & CBER
- Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations
- Considerations in Demonstrating Interchangeability With a Reference Product
CBER
CDRH
- Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)
- Medical X-Ray Imaging Devices Conformance with IEC Standards
- Policy Clarification for Certain Fluoroscopic Equipment Requirements
- Utilizing Animal Studies to Evaluate Organ Preservation Devices
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
- Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
- Unique Device Identification: Convenience Kits
Posted in Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices.