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 To this end, we are providing draft guidance and seeking additional feedback from a wide range of stakeholders and the public to help us consider how we may enhance this resource as we pursue the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

Coronavirus (COVID-19) Update: Daily Roundup May 22, 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 warned, Apollo 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 warned, North 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.

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

Coronavirus Diseas

Coronavirus (COVID-19) Update: Daily Roundup May 20, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic: The U.S. Department of Agriculture (USDA) and the FDA announced that the agencies signed a Memorandum of Understanding (MOU) to support the U.S. food and agriculture sector so that Americans can continue to have access to a safe and robust food supply. As a next step in carrying out Executive Order 13917, the MOU sets up a process to help prevent interruptions at FDA-regulated food facilities, including fruit and vegetable processing, in which the two agencies can make determinations about circumstances in which the USDA could exercise its authority under the Defense Production Act. The FDA issued an Emergency Use Authorization (EUA) to Walter Reed National Military Medical Center for the COVID-19 Airway Management Isolation Chamber (“CAMIC”) to be used by healthcare providers within the U.S. Army and Military Health System as an extra layer of barrier protection, in addition to personal protective equipment, to prevent exposure to pathogenic biological airborne particulates during transport of patients, at the time of definitive airway management, or when performing medical procedures on such patients during the COVID-19 pandemic. The CAMIC system is a barrier device constructed by draping a large clear plastic bag over a box-like frame that is placed over the head, neck, and shoulders of the patient to isolate (i.e., capture and remove) airborne particulates.

The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for promoting and participating in the sale of 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 company warned, Life Unlearned, LLC, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of vitamin D products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The second company warned, SpiceTac, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of vitamin C products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 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 105 tests under EUAs, which include 92 molecular tests, 12 antibody tests, and 1 antigen test.

Coronavirus Disease 2019 (COVID-1

Concern over Coronavirus Leading to Global Spread of Fake Pharmacy Spam

https://www.imperva.com/blog/concern-over-coronavirus-leading-to-global-spread-of-fake-pharmacy-spam/?utm_source=LinkedIn&utm_medium=boost_social&utm_content=Coronavirus&utm_campaign=2020_q1_twitter_awareness

FDA extends comment period on animal drug compounding draft guidance to June 17

https://www.pharmacist.com/article/fda-extends-comment-period-animal-drug-compounding-draft-guidance-june-17

Episode 41: Advocating for the Compounding Industry with ...

pccarx.podbean.com › episode-41-advocating-for-the-c...

18 hours ago - Scott Brunner, CAE, CEO of the Alliance for Pharmacy Compounding (APC, formerly IACP), joins co-hosts Mike De Lisio and Sebastian Denison, RPh, FAARM

USA - Epinephrine and morphine added to FDA's COVID-19 ...

www.ris.world › usa-epinephrine-and-morphine-added-...

18 hours ago - USA – Epinephrine and morphine added to FDA's COVID-19 compounding lists ... drugs that can be compounded by registered outsourcing facilities and some ...

May 20, 2020 MasterPharm Compounding Pharmacy — Did they Endanger Patients with FinPlus?

https://www.jdsupra.com/legalnews/masterpharm-compounding-pharmacy-did-22551/

May 20, 2020 Compounding Pharmacies Have Been on FDA’s Radar Since 2012

https://www.jdsupra.com/legalnews/compounding-pharmacies-have-been-on-fda-15628/

Coronavirus (COVID-19) Update: Daily Roundup May 21, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic: Today, the FDA posted a list of antibody tests that are being 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 Emergency Use Authorization (EUA) request or issued EUA. The FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on the notification list pending review of their EUA request. The FDA issued the guidance “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” to help foster the continued availability of medical devices during the COVID-19 public health emergency. As described in the guidance, the FDA does not intend to object to limited modifications to the design and manufacturing of devices approved through either a PMA or HDE without prior submission of a PMA or HDE supplement or 30-day notice for the duration of the public health emergency. The policy set forth in the guidance does not apply to design or manufacturing changes made for reasons other than addressing manufacturing limitations or supply chain issues resulting from the COVID-19 public health emergency or to any proposed changes described in a regulatory submission already received by FDA.

The FDA approved two abbreviated new drug applications:  Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures. The most common side effects of dexmedetomidine hydrochloride injection are hypotension, bradycardia, and dry mouth. This drug is listed in the FDA Drug Shortage Database. Succinylcholine chloride injection USP 200 mg/10 mL, is indicated in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.

Due to the COVID-19 pandemic and its impacts, earlier this month the U.S. District Court for the Eastern District of Texas granted a joint motion in the case of R.J. Reynolds Tobacco Co. et al. v. U.S. Food and Drug Administration et al. to govern proceedings in that case and postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule by 120 days. The new effective date of the final rule is Oct. 16, 2021. The FDA intends to update its relevant guidances related to the rule’s effective date and the timing for submission of cigarette plans. 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 105 tests under EUAs, which include 92 molecular tests, 12 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)

Coronavirus Disease 2019 (C