Friday, May 29, 2020

FDA In Brief: FDA Takes Actionsto Enhance Utility of the Orange Book

FDA In Brief: FDA Takes Actionsto Enhance Utility of the Orange Book

The following quote is attributed to Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research: 
“Providing timely and accurate information about generic drugs supports the FDA’s priority of facilitating the timely development and approval of these products and fostering competition in the marketplace.

  • “First published as an official list in 1980, one of the fundamental tools for providing information about generic drugs to the public is the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, more commonly known as the Orange Book.
  • “In October, we will celebrate the 40th anniversary of the Orange Book, which is one of the most used resources on FDA.gov. Although the Orange Book already provides extensive information about approved drug products, we want to ensure that it provides as much value as possible to those that rely on it, including consumers, health care professionals and drug developers. To this end, we are providing draft guidance and seeking additional feedback from a wide range of stakeholders and the public to help us consider how we may enhance this resource as we pursue the ultimate goal of improving access to high quality, affordable treatment options for Americans.”
Additional Information:
 
  • Today, the U.S. Food and Drug Administration issued a Federal Register notice to open a docket for submission of public comment on the publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the "Orange Book.” The FDA would like to know how stakeholders and the public use the Orange Book and how it can be improved to make sure the published information is clear and helpful. In addition to general comments, the FDA is interested in learning what types of people or entities use the Orange Book and which sections are most useful to...

Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection


Today the U.S. Food and Drug Administration took steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website. As explained in FDA’s guidance, Policy for COVID-19 Tests During the Public Health Emergency (Revised), this template reflects FDA’s current thinking on the data and information that developers should submit to facilitate the EUA process. In particular, this template includes recommendations for use by laboratories and commercial manufacturers who may use it to facilitate the preparation and submission of an EUA request. Currently, developers can offer a COVID-19 test for at-home self-collection under emergency use authorization (EUA), and COVID-19 tests for at-home self-collection may also be used as part of an Institutional Review Board (IRB)-approved study.

“During this pandemic, the FDA has remained supportive of making accurate and reliable tests widely available. Home collection raises unique concerns about safety and accuracy – for example, can the sample be collected safely and properly by a layperson, can the sample be shipped in a way that’s stable to ensure an accurate result once it reaches the lab, among other factors – which is why these tests require FDA review, to ensure they work as they should and are safe for all involved. An at-home test that returns false results could be harmful to an individual patient, and hinder broader public health efforts to mitigate the spread of COVID-19,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We’ll continue to support ways of making our review processes as streamlined as possible, while continuing to protect patients and the public health.”

 For COVID-19 diagnostic tests that use at-home specimen collection kits and are intended for use in clinical decision making, developers are generally required to submit a request for an EUA prior to distribution and use of such test. In cases where the developer has not obtained an EUA, these tests may be...

Wednesday, May 27, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  •  Today, FDA and the U.S. Department of Agriculture released recommendations to help address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industry during the COVID-19 pandemic.
  • The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures and highlights of the agency's response efforts.
  • The FDA issued a guidance document to provide additional temporary flexibility in food labeling requirements to manufacturers and vending machine operators. The agency is providing flexibility for manufacturers to make minor formulation changes in certain circumstances without making conforming label changes. Also, the FDA is providing temporary flexibility to the vending machine industry and will not object if covered operators do not meet vending machine labeling requirements to provide calorie information for foods sold in the vending machines at this time. 
  • In a new video, Donate Blood and Plasma to Make a Difference, the FDA explains one way you can make a difference is to donate blood or plasma if you are eligible to donate.
  • The FDA and the Federal Trade Commission issued a warning letter to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
  • The first seller warnedApollo Holding LLC, offers “NoronaPak” products, including cannabidiol (CBD) and other supplement products for sale in the U.S. with claims that misleadingly represent the products as safe and/or effective for the prevention and treatment of COVID-19.
  • The second seller warnedNorth Coast Biologics LLC, has offered the unapproved “nCoV19 spike protein vaccine” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention of COVID-19.
  • The FDA updated the FAQs on Testing for SARS-CoV-2 to clarify information about at-home self-collection and what tests should no longer be distributed for COVID-19.
  • Test developers can offer their COVID-19 tests for at-home self-collection of a specimen if at-home self-collection of a specimen is specifically authorized under the Emergency Use Authorization (EUA) for the test. In addition, COVID-19 tests for at-home self-collection may be used as part of an Institutional Review Board-approved study. The FDA is supportive of at-home self-collection and has authorized several COVID-19 tests for home collection of specimens to be sent to a laboratory for processing and test reporting.
  • The FDA added a new section to the FAQs to clarify what tests should no longer be distributed for COVID-19. Yesterday, the FDA posted a list of commercial manufacturers’ antibody tests that have been removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending EUA request or issued EUA. FDA expects that the tests on the removal list will not be distributed.
  • Testing updates:
  • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
  • To date, the FDA has authorized 109 tests under EUAs, which include 96 molecular tests, 12 antibody tests, and 1 antigen test.