|
The latest from FDA
 Register now to share your long COVID experience with FDA
Public Meeting on Patient-Focused Drug Development for Long COVID
April 25, 2023
FDA is hosting a virtual public meeting on patient-focused drug development for long COVID. This meeting will provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of long COVID, including how long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating long COVID, and what they consider when determining whether or not to participate in a clinical trial.
This virtual public meeting will be conducted with live translation in both English and Spanish.
Reunión pública sobre el desarrollo de medicamentos centrados en el paciente contra el COVID-19 persistente
El 25 de abril de 2023
La Administración de Alimentos y Medicamentos de EE. UU. (FDA, por sus siglas en inglés) organizará una reunión pública virtual sobre el desarrollo de medicamentos centrados en el paciente contra el COVID-19 persistente. Esta reunión brindará a la FDA la oportunidad de obtener aportes iniciales de los pacientes y de los representantes de estos sobre aspectos del COVID-19 persistente, como la forma en que afecta la vida diaria, los síntomas que los pacientes consideran de mayor importancia, los enfoques actuales para tratar el COVID-19 persistente y las consideraciones para la participación en estudios clínicos.
Esta reunión pública virtual se llevará a cabo con traducción en vivo tanto en inglés como en español.
|
|
Emergency Use Authorization (EUA) updates
FDA issues final guidances to assist with transition plans for COVID-19 related medical devices
FDA finalized two guidances:
These guidances outline FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations. The recommendations include information for devices that fall within certain enforcement policies issued during the COVID-19 public health emergency (PHE) under section 319 of the Public Health Service Act and devices issued EUAs related to COVID-19 under section 564 of the Federal Food, Drug, and Cosmetic Act, including:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
There will be a 180-day transition period for impacted devices to help avoid disruption in device supply and help ensure an orderly and transparent transition (specific information on the scope and the timeline for the transition period can be found in each guidance).
FDA encourages stakeholders to plan for the transition process by reviewing the two final guidances, attending the upcoming webinar, and contacting FDA if they have questions. If manufacturers with impacted devices plan to continue distributing their devices after either the end of the transition period following the expiration of the COVID-19 PHE or termination of the relevant device EUA declaration related to COVID-19, FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances. (March 24, 2023)
COVID-19 in vitro diagnostic (test) EUAs
As of March 28, 2023, 445 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and 5 EUAs for molecular OTC at-home tests. FDA has authorized 45 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,324 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
|
|
|
Events
-
March 28-29, 2023: Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review (virtual)
-
March 30, 2023: Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation Public Workshop (virtual)
-
April 17, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The applicant's proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and carbapenem-resistant strains.
-
New! April 18, 2023: Webinar on Guidances on COVID-19 Transition Plans for Medical Devices (1:00 - 2:30 p.m. ET) - FDA will host a webinar for stakeholders interested in learning more about the two final guidances on the Coronavirus Disease 2019 (COVID-19) transition plans for medical devices.
-
April 24-28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - To attend virtually, pre-register by April 14, 2023.
-
April 25, 2023: Public Meeting on Patient-Focused Drug Development for Long COVID (virtual) - This virtual public meeting will be conducted with live translation in both English and Spanish. To attend, please register.
Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.
|
|
Information for industry and health care providers
FDA issues framework for digital health technologies
FDA issued the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (PDF). The Digital Health Technology (DHT) framework document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
The document outlines the framework FDA will use to implement a multifaceted DHT program for drugs and biological products. The DHT program will engage stakeholders and include workshops and demonstration projects; establish internal processes to support DHT evaluation for use in drug development; promote shared learning and consistency for DHT-based policy, procedure, and analytic tool development; and facilitate the publication of relevant guidance documents. (March 24, 2023)
Reminder: How COVID-19-related guidances will be impacted by the expiration of the COVID-19 public health emergency
FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents FDA is revising to temporarily continue in effect. Learn more (March 13, 2023)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
|
|
In case you missed it
MCMi FY 2022 Program Update
In February, FDA published the Medical Countermeasures Initiative (MCMi) Program Update report for fiscal year 2022, which showcases FDA's work each year to prepare for all types of public health emergencies. Download a printable PDF.
|
Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you.
|
List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 380 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
|
Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|
