Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

Agency Additionally Warns Consumers about Hand Sanitizer Sold with Fraudulent Claims

Today, the U.S. Food and Drug Administration provided an update on its efforts to ensure the availability of alcohol-based sanitizer to help meet the demand for hand sanitizer during the COVID-19 pandemic. As a result of the agency’s significant flexibility, more than 1,500 additional manufacturers have registered with the agency to produce hand sanitizer. At the same time, the agency is addressing safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims. “We appreciate industry’s willingness to help supply alcohol-based hand sanitizer to the market to meet the increasing demand for these products and are grateful for their efforts,” said FDA Commissioner Stephen M. Hahn, M.D. “With this increased supply comes our continued mission to ensure safety of these products. It is important that hand sanitizer be manufactured in a way that makes them unpalatable to people, especially young children, and that they are ...

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Coronavirus (COVID-19) Update: Daily Roundup April 27, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, the FDA issued a statement, “Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Address Safety Concerns,” to discuss the Agency’s efforts to increase availability of alcohol-based hand sanitizer and the importance of making hand sanitizer unpalatable to people, including children, through the use of denatured alcohol. Calls to the National Poison Data System last month related to hand sanitizer increased by 79 percent compared to March 2019, with the majority of these calls accounting for...

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FDA Approves First Generic Detomidine Hydrochloride Injectable Solution for Horses

The FDA’s Center for Veterinary Medicine has approved the first generic detomidine hydrochloride injectable solution for horses. Generic detomidine hydrochloride is indicated for use as a sedative and analgesic (pain reliever) to facilitate minor surgical and diagnostic procedures in mature horses and yearlings (adolescent horses) and is an important tool in enabling these animals to receive treatment while managing pain during minor surgical procedures, such as repairing skin lacerations. The sponsor of an abbreviated new animal drug application (ANADA) for a generic animal drug is required to show that the generic product is bioequivalent to the reference listed new animal drug (in this case, Dormosedan), which has been shown to be safe and effective.  Bioequivalence means that the bioavailability of a generic new animal drug and the referenced listed new animal drug (RLNAD) must be the same, meaning that the extent and rate of absorption of the active pharmaceutical ingredient(s) (API) or its metabolite(s) are equal, therefore behaving and acting in the same manner as Dormosedan. The generic drug product is an injectable solution, contains the same active ingredient in the same concentration and dosage form as the RLNAD, and contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.

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COVID-19 Update: CMS and Ohio Board of Pharmacy issue new and updated regulatory waivers

https://www.jdsupra.com/legalnews/covid-19-update-cms-and-ohio-board-of-30585/

Imprisoned CEO says COVID-19 justifies release from prison

TERRE HAUTE, Ind. (AP) — The former CEO of a central Indiana compounding pharmacy is trying to win release from federal prison, saying he fears he’ll die behind bars from COVID-19 while ...

SFGate3d

FBI agents raid Ocean Springs pharmaceutical company

FBI agents raid Ocean Springs pharmaceutical company

Federal agents armed with search warrants raided Gulf Coast Pharmaceuticals Plus in Ocean Springs on Friday. The business on ...

Biloxi Sun Herald

Utah Has Already Spent $800,000 On Controversial Medication Touted By Trump As COVID-19 Treatment By KUER NEWS • 2 MINUTES AGO

https://www.kuer.org/post/utah-has-already-spent-800000-controversial-medication-touted-trump-covid-19-treatment#stream/0

Temporary FDA Policy for Compounding COVID-19 Drugs Poses Opportunitie...

Temporary FDA Policy for Compounding COVID-19 Drugs Poses Opportunitie...: With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. To fill that gap, the FDA recentl...

Animal Drugs @ FDA Explained

Animal Drugs @ FDA is a searchable online database that includes most FDA-approved and conditionally approved animal drugs. Indexed animal drugs are not listed in Animal Drugs @ FDA. At the top of the page, you can do either a quick search or an advanced search of the database using several parameters, including proprietary name (also known as trade name or brand name), active ingredient, and application number. New Animal Drug Applications are for approved brand name animal drugs and Abbreviated New Animal Drug Applications are for approved generic animal drugs. Animal Drugs @ FDA also includes supporting documents for approved animal drugs.

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Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain Tobacco Products Because of Impacts from COVID-19 The following is attributed to FDA commissioner Stephen M. Hahn, M.D.

On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020. We have steadily been working toward that deadline, but the coronavirus pandemic has drastically impaired the ability to adhere to this timeline. Solely as a result of the pandemic and these exceptional and unforeseen circumstances, we requested on March 30, and on April 22, 2020 were granted by the court, a 120-day extension of the May 12 deadline. The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to ...

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