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Clinical Pharmacology Modeling SimulationNew FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings
| Special Interest Guidances/Information | Date Posted |
| Providing Regulatory Submissions in Electronic Format -- Standardized Study Data | 29 October 2020 |
| Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry | 28 October 2020 |
| Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff | 28 October 2020 |
| Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date: Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff | 28 October 2020 |
| Referencing Approved Drug Products in ANDA Submissions Guidance for Industry | 27 October 2020 |
| Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies | 27 October 2020 |
| Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies | 22 October 2020 |
| Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry: Draft Guidance for Industry | 20 October 2020 |
| Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels | 16 October 2020 |
| Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration | 16 October 2020 |
| Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry | 16 October 2020 |
| FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry | 16 October 2020 |
| Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry | 15 October 2020 |
| Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff | 15 October 2020 |
| Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin: Draft Guidance for Industry and Food and Drug Administration Staff | 15 October 2020 |
| Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff | 13 October 2020 |
| Premenopausal Women with Breast Cancer: Developing Drugs for Treatment: Draft Guidance for Industry | 07 October 2020 |
| Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry | 01 October 2020 |
| Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry | 01 October 2020 |
| Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment: Draft Guidance for Industry | 01 October 2020 |
| Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment: Draft Guidance for Industry | 01 October 2020 |
| Upcoming Meetings (* = New) | |
| * | Nov 6, 2020: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting |
| * | Nov 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement |
| * | Dec 15, 2020: Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement |
| * | Dec 16, 2020: Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement |
Last updated: 03 November 2020