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 To this end, we are providing draft guidance and seeking additional feedback from a wide range of stakeholders and the public to help us consider how we may enhance this resource as we pursue the ultimate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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05/26/2020

01/13/2020

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Office of Pharmaceutical Quality Operations, Division II

Compounding Pharmacy/Adulterated Drug Products

05/27/2020	05/26/2020	CBD Gaze	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/27/2020	05/26/2020	Alternativa	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/27/2020	05/26/2020	Musthavemom.com	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/27/2020	05/26/2020	Careful Cents, LLC	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

5/26/2020

03/12/2020

Altaire Pharmaceuticals, Inc.

Division of Pharmaceutical Quality Operations I

CGMP/Finished Pharmaceuticals/Adulterated

05/26/2020

04/20/2020

Humaworm

Office of Human and Animal Foods Operations East 5

Unapproved New Drugs/Misbranded

05/26/2020

05/13/2020

Samchundang Pharm Co., Ltd.

Center for Drug Evaluation and Research | CDER

CGMP/Finished Pharmaceuticals/Adulterated

05/26/2020	05/13/2020	88 Special Sweet, Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
05/26/2020	05/14/2020	D.K. Grocery Inc. DBA Apna Bazaar Cash and Carry	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
05/26/2020	05/14/2020	Maspeth Wholesale Corp	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)