By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS

Special Interest Guidances/Information Date Posted
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Final Guidance 31 Jul 2020
Multiple Function Device Products: Policy and Considerations – Final Guidance 29 Jul 2020
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval – Final Guidance (Revision 1) 29 Jul 2020
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format – Draft Guidance (Revision 1) 29 Jul 2020
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products – Final Guidance 29 Jul 2020
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products – Draft Guidance 28 Jul 2020
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products:  Minimal Manipulation and Homologous Use – Final Guidance 21 Jul 2020
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research – Draft Guidance 21 Jul 2020
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency – Final Guidance 20 Jul 2020
Clinical Investigations for Prostate Tissue Ablation Devices – Final Guidance 15 Jul 2020
Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act – Final Guidance 15 Jul 2020
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections – Final Guidance 10 Jul 2020
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies – Final Guidance 10 Jul 2020
Cancer Clinical Trial Eligibility Criteria: Brain Metastases – Final Guidance 10 Jul 2020
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients – Final Guidance 10 Jul 2020
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking – Final Guidance 01 Jul 2020

 

Upcoming Meetings (* = New)
* Sep 08-09, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
* Aug 18-19, 2020: Science Advisory Board to the National Center for Toxicological Research 2020 Meeting
* Aug 13, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting

Last updated: 04 August 2020

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