Compounding: Regulatory Policy Information - American College for Advancement in Medicine (ACAM)

Compounding: Regulatory Policy Information - American College for Advancement in Medicine (ACAM)

Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic: The agency issued a new FDA Voices, titled Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety, and bylined by Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response. In March, the FDA was a few days away from announcing the release of the New Era of Smarter Food Safety Blueprint when the FDA’s focus turned to the COVID-19 pandemic. Plans for the New Era initiative were rightfully put on hold in order to prioritize the agency’s COVID-19 response. The FDA will release the blueprint in the coming weeks, outlining plans over the next decade to create a more digital, traceable, and safer food system. The FDA published guidance, titled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators, which includes recommendations regarding procedures for single IRB member review. This is in response to physician requests for a waiver from the requirement for full IRB review. The guidance recommendations also address factors to consider when assessing potential benefits and risks for a particular patient being treated under expanded access. The FDA added a second ventilator developed by NASA to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA) that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored to provide respiratory support for COVID-19 patients who are experiencing respiratory failure or insufficiency. Where the first NASA ventilator relied on wall gas as the pressure source, the second ventilator uses an internal compressor for its energy source. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators.

The FDA added an emergency resuscitator for the Fitbit Flow to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA). The Fitbit Flow is a continuous respiratory support system that includes an FDA-cleared Manual Resuscitator. The accessory is an AMBU bag with audible and visual alarms that aid the performance of the manual resuscitator for continuous breathing. This design is intended for use in treating patients with COVID-19. The FDA, in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of pediatric product development plans for the treatment and prevention of COVID-19. In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP). The FDA recognizes the vital role of health professionals in the fight against COVID-19. In order to help health professionals quickly and easily access FDA resources, we created a new web page, titled Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals. This page contains links to FDA emergency use authorizations; information about personal protective equipment and other medical products for use during COVID-19.  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 119 tests under EUAs, which include 103 molecular tests, 15 antibody tests, and 1 antigen test.

Additional Resources: FAQs on Testing for SARS-CoV-2 Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

06/02/2020

05/15/2020

LifeHealth Science

Division of Human and Animal Food Operations East V

Unapproved New Drugs/Misbranded

06/02/2020

05/22/2020

Frontier Vapor

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

06/02/2020

04/22/2020

Flame On, Inc. d/b/a USA Less

Center for Tobacco Products

Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

Coronavirus (COVID-19) Update: Daily Roundup June 1, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic: On May 29, the FDA issued a new FDA Voices, Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic. It explains how the agency plays a pivotal role helping to both move new medical products to patients as soon as possible and evaluate the potential benefits and risks of these new products.  The FDA issued a Consumer Update, Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19. Scientists are working hard to develop a number of potential drugs for the prevention or treatment of coronavirus, but none are currently approved by the FDA for these purposes. The language used to describe potential therapies can be confusing, and there’s public interest around the FDA’s work to ensure access to potentially life-saving treatments. This Consumer Update explains some of the regulatory terminology. 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 117 tests under EUAs, which include 101 molecular tests, 15 antibody tests, and 1 antigen test.

Federal judge enters order of permanent injunction against New York company for distributing unapproved drugs

A federal judge has ordered two individuals doing business as Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until they comply with federal law. According to the complaint, despite previous warnings from the U.S. Food and Drug Administration and repeated promises to correct violations, Sundial continued to violate the law and distribute their products. “Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. Making claims that unproven drugs can cure or prevent diseases places consumers’ health at risk,” said FDA Chief Counsel Stacy Amin. “We remain committed to pursuing and taking swift action against those who attempt to ...

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NDMA Prompts Metformin Recall — FDA finds certain products with excessive levels of potential carcinogen by Kristen Monaco, Staff Writer, MedPage Today May 29, 2020

https://www.medpagetoday.com/primarycare/diabetes/86757?xid=nl_mpt_DHE_2020-05-30&eun=g649657d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-05-30&utm_term=NL_Daily_DHE_dual-gmail-definition

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...

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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...

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