Monday, August 30, 2021


The indictment alleges that Holmes and Balwani defrauded doctors and patients (1) by making false claims concerning Theranos's ability to provide accurate, fast ...


9 hours ago — Theranos was subsequently sued by investors for fraud, had its blood-testing license revoked by the US government, settled "massive fraud" ...
20 hours ago — Elizabeth Holmes Plans To Accuse Ex-Boyfriend Of Abuse At Theranos Fraud Trial ... Both she and Balwani, who will be tried separately next year, ...
3 days ago — Elizabeth Holmes, the founder of blood-testing startup Theranos, plans to defend herself at her federal fraud trial starting next week by ...
55 minutes ago — Theranos founder Elizabeth Holmes goes on trial in coming days on charges that she defrauded investors and patients about her blood-testing ...

Thursday, August 26, 2021


FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health

Action Marks First Marketing Denial Orders for E-Cigarette Products; Products Receiving Such Orders Must be Removed from the Market or Risk Enforcement; More Marketing Decisions to Follow

Today, the U.S. Food and Drug Administration issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining the applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.

“Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” said Acting FDA Commissioner Janet Woodcock, M.D. “Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”

This action represents a significant step toward making progress on the unprecedented number of applications received by the Sept. 9, 2020 court-ordered deadline for submission of premarket applications for deemed new tobacco products, and addressing youth use of flavored ENDS products.

The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. Although the agency has issued other negative actions for some applications, this is the first set of MDOs the FDA has issued for applications that have reached the substantive scientific review portion of premarket review. The agency is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that they are “appropriate for the protection of the public health.”

The products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement. The MDOs announced today do not include all ENDS products for which the companies submitted applications. Applications for the rest of the products remain under consideration. The FDA had previously notified one of the companies, JD Nova Group LLC, that their premarket tobacco product applications associated with approximately 4.5 million of their products did not meet the filing requirements for a new tobacco product seeking a marketing authorization.

“Flavored ENDS products are extremely popular among youth, with over 80 percent of e-cigarette users between ages 12 through 17 using one of these products. Companies who want to continue to market their flavored ENDS products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.’ If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.”

The FDA’s review of new tobacco products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health. In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable. Because this evidence was absent in these applications, the FDA is issuing MDOs.

The agency will continue to review other premarket tobacco applications for non-tobacco flavored ENDS to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth. If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization. But in the absence of this evidence, the agency intends to issue an MDO.

The scientific review of menthol ENDS, as compared to other non-tobacco-flavored ENDS products, raises unique considerations. Although menthol-flavored ENDS are not included in the decisions described above, the FDA notes that its reviews will similarly examine whether the evidence in the application demonstrates a benefit to existing adult users that outweighs the known youth use of such products.  

Tuesday, August 24, 2021


Joanne S. Eglovitch - Regulatory Affairs Professionals Society

18 hours ago — The US Food and Drug Administration (FDA) on 12 August released a Form 483 ... the agency to control the distribution of compounded drugs sold interstate


Ninth defendant pleads guilty in TRICARE scheme - Batesville ...

6 days ago — A ninth defendant has pleaded guilty in connection with a $12 million scheme to generate prescriptions for expensive compounded drugs paid for by TRICARE.


USP 797: A breakdown of low, medium and high risks

2 days ago — Knowing the level of risk corresponding to each compounded preparation is ... Take the guesswork out of USP medication compounding compliance with a ...


Maryland Board of Pharmacy To Host the National Boards of ...

4 days ago — Additional resources and information on the FDA MOU and the Compounding Pharmacy Information Sharing Project can be found through the Members section of the


TSBP Rules FAQ - Texas State Board of Pharmacy

5 days ago — Is a pharmacy allowed to distribute drugs to another pharmacy or a practitioner? ... Other than compounded preparations, a pharmacy should adhere to drug ..


Georgian pleads guilty in kickback scheme - The Arkansas ...

3 days ago — Myers collected nearly $70,000 for recruiting Tricare beneficiaries to receive expensive compounded drugs, for which Tricare paid over $340,000. Myers .


Arkansas Man Sentenced to Prison and Ordered to Pay ...

6 days ago — Compounded medications are personalized dosages or formulas normally made for ... for the prescription of compounded drugs to TRICARE beneficiaries.

Thursday, August 19, 2021


FDA Approves First Generic Amoxicillin and Clavulanate Potassium for Oral Suspension for Use in Cats and Dogs

The U.S. Food and Drug Administration has approved the first generic form of amoxicillin and clavulanate potassium for oral suspension for use in cats and dogs. Amoxicillin and Clavulanate Potassium for Oral Suspension is approved to treat susceptible skin and soft tissue bacterial infections (e.g., wounds, abscesses, cellulitis, etc.) in both dogs and cats. It is also approved to treat periodontal (gum) bacterial infections in dogs and urinary tract infections (cystitis) due to susceptible strains of E. coli in cats. The drug is a generic version of Clavamox Drops.

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Wednesday, August 18, 2021

FDA says more than 130 dog deaths, 220 illnesses may be linked to Midwestern Pet Foods Kelly Tyko USA TODAY 


FDA In Brief: FDA Issues a Corporate-Wide Warning Letter

2 days ago — The initial inspection of Midwestern's Chickasha, Oklahoma plant was triggered by reports of illness or death in dogs that had eaten SPORTMiX brand dry dog food ...
1 day ago — FDA considers that aflatoxin levels in dog and cat food above 20 ppb will support a charge of adulteration under section 402(a)(1) of the FD&C Act [21 U.S.C. § ...


A Pharmacist Sold COVID-19 Vaccine Cards For $10 On eBay ...

6 hours ago — Tangtang Zhao, 34, allegedly sold 125 authentic Centers for Disease Control and Prevention vaccination cards to 11 buyers in March and April.


Selling COVID Vaccination Cards Online - Department of Justice

1 day ago — Zhao was a licensed pharmacist in Illinois and was employed at Company 1, a pharmacy which distributed and administered COVID-19 vaccines at its physical ...


13 hours ago — Compounded Human Drug Products. We have not yet executed that document. ... pharmacy compounding. From your May 26, 2021 meeting:.

Georgian guilty in kickback scheme Defrauded U.S. insurer, he says by Dale Ellis | Today at 6:53 a.m. 

9th Defendant Pleads Guilty in $12M Tricare Scheme by Arkansas Business Staff Tuesday, Aug. 17, 2021 4:24 pm 2 min read