Updates
Consumer Updates
Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy
To survive, we need oxygen going from our lungs to the cells in our body. Sometimes the amount of oxygen in our blood can fall below normal levels. Asthma, lung cancer, chronic obstructive pulmonary disease (COPD), the flu, and COVID-19 are some of the health issues that may cause oxygen levels to drop. When the levels are too low, we may need to take extra oxygen, known as oxygen therapy.
One way to get extra oxygen into the body is by using an oxygen concentrator. Oxygen concentrators are medical devices required to be sold and used only with a prescription. [10/30/2020]
Guidance Documents - Request for Comment
Providing Regulatory Submissions in Electronic Format -- Standardized Study Data
Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in which the Food and Drug Administration (FDA) has specified the electronic format for submitting certain submission types to the Agency, such content must be submitted electronically and in the format specified by FDA.
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products
This guidance provides sponsors with recommendations on the nonclinical information to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications.
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA Insight
Join Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs, and other FDA leaders as they provide their insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics.
Webinars and Virtual Workshops
Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes--Exploring the Path Forward for Assessment
The purpose of the public workshop is to have scientific discussions on methods to evaluate the Opioid Analgesics Risk Evaluation and Mitigation Strategy (OA REMS).
December 11, 2020; 9:00 AM - 5:00 PM ET
Registration is not required.
Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss supplemental new drug application (sNDA) 207620-S18, for the angiotensin receptor-neprilysin inhibitor, ENTRESTO (sacubitril and valsartan) tablets, submitted by Novartis Pharmaceuticals Corp., for the proposed indication of heart failure with preserved ejection fraction (HFpEF).
December 15, 2020; 9:00 AM - 5:00 PM ET
Registration is not required.
Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
The committee will discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction (HFpEF), a serious and often fatal condition for which no drug is approved to improve outcomes. The data supporting the new indication are post-hoc analyses of the National Heart, Lung, and Blood Institute (NHLBI) sponsored TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial, which nominally failed to meet its primary endpoint. Spironolactone is currently marketed in the US for the treatment of heart failure with reduced ejection fraction, hypertension, primary hyperaldosteronism, and for the management of edema.
December 16, 2020; 9:00 AM - 1:30 PM ET
Registration is not required.
About Us
The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders. We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living.
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