John Pugh, Wilbur Davenport, and Cole Brothers Circus Inc., entered plea agreements yesterday in U.S. District Court in Beaumont, Texas to resolve Endangered Species Act (ESA) violations related to the purchase and sale of two Asian elephants named “Tina” and “Jewel.”

Mohammad Jafar Nikbakht, aka Freydoon Nikbakht, pleaded guilty to tax evasion before U.S. District Court Judge John A. Houston in San Diego.

Karen L. Blyth and David H. M. Phelps were sentenced yesterday in federal court in Mobile, Ala., to 33 months and 24 months in prison, respectively. The pair was also fined $5,000 each, and barred for three years from working in the seafood industry or owning any seafood related business.

VeriFone Systems Inc., Hypercom Corp. and Ingenico S.A. have abandoned plans for Hypercom to divest its U.S. point-of-sale business to Ingenico.

A former U.S. Army sergeant pleaded guilty today to conspiring to steal U.S. Army equipment related to his work as a non-commissioned officer helping to train Iraqi army personnel in Mosul, Iraq, in 2008.

“The international expansion and increased violence of transnational criminal networks pose a significant threat to the United States."

The Department of Justice announced today that, in order for VeriFone Systems Inc. to complete its acquisition of Hypercom Corp., it must divest Hypercom’s U.S. point-of-sale terminals business to an entity sponsored by Gores Group LLC, a private equity fund.

Nicholas J. Faranso of Farmington Hills, Mich., was sentenced today by U.S. District Court Judge John Corbett O’Meara in the Eastern District of Michigan to one year and one day in prison for conspiring to defraud the United States.

A 15-count indictment returned by a federal grand jury in Camden, N.J., was unsealed today following the arrest of six individuals from New Jersey and Maryland, and the seizure or restraint of 10 oyster fishing boats in New Jersey, announced Ignacia S. Moreno, Assistant Attorney General for the Justice Department’s Environment and Natural Resources Division, and Paul J. Fishman, U.S. Attorney for the District of New Jersey.

Online search engine Google Inc. has agreed to forfeit $500 million for allowing online Canadian pharmacies to place advertisements through its AdWords program targeting consumers in the United States, resulting in the unlawful importation of controlled and non-controlled prescription drugs into the United States.

The Justice Department filed a lawsuit today against the developers, builders and designers of the Gateway Village Apartments, a 275-unit apartment complex in Salem, Ore., for violations of the Fair Housing Act.

The United States alleged that the Pompano Beach, Fla.,and Jacksboro, Tenn., companies manufactured and sold Zylon bulletproof vests despite possessing information showing that the Zylon materials degraded quickly over time and were not suitable for ballistic use.

The United States has filed suit against Sonkei Communications Inc., and its principal corporate officers, Peter Turpel and Joseph Turpel.

William A. Herder of Mifflin Township, Ohio, was arrested today on federal tax charges.

Americall Group Inc. (AGI), a Naperville, Ill., telemarketing company specializing in sales for financial service and insurance companies, has agreed to settle charges that AGI violated “do not call” provisions of the Telemarketing Sales Rule.

BizJet International Sales and Support Inc., a provider of aircraft maintenance, repair and overhaul (MRO) services based in Tulsa, Okla., has agreed to pay an $11.8 million criminal penalty to resolve charges related to the Foreign Corrupt Practices Act (FCPA) for bribing government officials in Latin America to secure contracts to perform aircraft MRO services for government agencies.

The Department of Justice has seized more than $896,000 in proceeds from the distribution of counterfeit sports apparel and jerseys as the result of an investigation into the sale of counterfeit goods on commercial websites.

Thomas Mitchell of Mansfield, Ohio pleaded guilty before United States District Judge George J. Limbert of the Northern District of Ohio to criminal information charging him with willfully failing to file an income tax return with the Internal Revenue Service (IRS), the Justice Department and IRS announced today.

The investigation also resulted in the seizure of three domain names used in the sale of counterfeit sports apparel.

A jury convicted William A. Herder of Richland County, Ohio, yesterday on federal tax charges, the Justice Department and Internal Revenue Service (IRS) announced.

Paul Cosgrove, the former Head of Worldwide Sales at Rancho Santa Margarita, Calif.-based valve company Control Components Inc. (CCI) pleaded guilty today to violating the Foreign Corrupt Practices Act.

William R. Herder of Bellville, Ohio, was arrested today on federal tax charges, Assistant Attorney General of the Justice Department’s Tax Division Kathryn Keneally, U.S. Attorney for the Northern District of Ohio Stephen M. Dettelbach and Special Agent in Charge, Internal Revenue Service (IRS) Criminal Investigation, Cincinnati Field Office, Darryl K. Williams announced. On June 19, 2012, a federal grand jury sitting in Cleveland returned an indictment against Herder, charging him with corruptly endeavoring to impair and impede the due administration of the Internal Revenue laws, failure to file tax returns, failure to pay taxes, and structuring transactions to evade currency reporting requirements.

Dr. Ellen Meredith Stubenhaus, previously of Lake Worth, Fla., and later an expatriate living in Costa Rica, was sentenced to 60 months in prison today by U.S. District Judge M. Casey Rodgers in Tallahassee, Fla., the Justice Department and Internal Revenue Service (IRS) announced. Stubenhaus, who was extradited from Costa Rica to the United States in September 2011, had previously pleaded guilty to conspiracy to defraud the United States. In addition to her jail sentence, Stubenhaus was sentenced to three years of supervised release and ordered to pay restitution of $373,549 to the IRS.

After a seven week trial in federal court in Camden, N.J., multiple defendants were convicted on various felony counts of creating false records, trafficking in illegally possessed oysters, obstructing the Food and Drug Administration’s regulation of public health and safety, and conspiring to commit those crimes.

The former owners of a durable medical equipment (DME) wholesale company located in Ontario, Calif., were arrested late yesterday at Los Angeles International Airport in connection with a DME fraud scheme that resulted in the submission of over $16.6 million in false claims to Medicare and are expected to appear this afternoon in Los Angeles federal court.

A federal judge today sentenced William A. Herder of Richland County, Ohio, to 37 months in prison for tax crimes, the Justice Department and the Internal Revenue Service (IRS) announced. U.S. District Judge Sara Lioi also ordered Herder to pay restitution to the IRS. On May 21, 2012, an Akron, Ohio, jury convicted Herder on all counts of an indictment that charged Herder with one count of tax evasion, one count of corruptly endeavoring to obstruct the administration of the Internal Revenue laws and five counts of willful failure to file tax returns.

William R. Herder of Bellville, Ohio, pleaded guilty yesterday to corruptly endeavoring to obstruct the administration of the tax laws and currency structuring, Assistant Attorney General for the Justice Department’s Tax Division Kathryn Keneally, U.S. Attorney for the Northern District of Ohio Stephen M. Dettelbach and Special Agent in Charge, Internal Revenue Service (IRS) - Criminal Investigation, Cincinnati Field Office, Darryl K. Williams announced. Herder was previously indicted in June of this year.

Mohammad Jafar Nikbakht, aka Freydoon Nikbakht, was sentenced Friday to 15 months in prison for evading his individual income taxes.

Roland Kaufmann, CEO of Axius Inc., pleaded guilty today in Brooklyn for conspiring to bribe stock brokers.

A federal judge in Cleveland today sentenced William R. Herder of Bellville, Ohio, to 20 months in prison for tax crimes.

Louis Daniel Smith, 42, and Karis Delong, 38, both of Ashland, Ore., were charged with defrauding regulators and suppliers in a scheme to manufacture and sell industrial bleach as a cure for numerous illnesses, including arthritis, cancer and the seasonal flu.

Two former owners of a Los Angeles-area medical equipment wholesale supply company pleaded guilty today to conspiring with their customers to defraud Medicare.

Roland Kaufmann, CEO of Axius, Inc., was sentenced today to serve 16 months in prison for his role in a conspiracy to bribe purported stock brokers and manipulate the stock of a company he controlled.

Attorney General Eric Holder and U.S. Attorney for the Western District of North Carolina Anne M. Tompkins announced today that the United States has filed a civil lawsuit against Bank of America Corporation and certain of its affiliates, including Merrill Lynch, Pierce, Fenner &Bank of America”).

Boston Scientific Corp. and its subsidiaries, Guidant LLC, Guidant Sales LLC and Cardiac Pacemakers Inc. (Guidant), have agreed to pay $30 million to settle allegations that, between 2002 and 2005, Guidant knowingly sold defective heart devices to health care facilities that in turn implanted the devices into Medicare patients.

Ari B. Goldenberg, 46, of Milton, N.H., was charged today with trafficking in and making a false record for illegally selling a black rhinoceros head mount to an undercover U.S. Fish & Wildlife Service (FWS) special agent.

SAN JUAN, Puerto Rico – Manuel Garcia-Figueroa, a resident of Playa Añasco, Puerto Rico, pleaded guilty to a bill of information charging him with a felony violation of the Lacey Act for the illegal sale of sea turtle meat, the Justice Department announced today.

Four commercial fishermen and one company were indicted yesterday by a federal grand jury in Baltimore for a criminal conspiracy involving the illegal harvesting and interstate sale of striped bass on the Chesapeake Bay.

A Newington, Connecticut, man was indicted last Thursday by a grand jury in the District of Connecticut for one count of corruptly interfering with the due administration of the internal revenue laws, two counts of filing false tax returns and five counts of willfully failing to file tax returns, the Justice Department and Internal Revenue Service (IRS) announced

A former salesman at a prominent Los Angeles car dealership and another Southern California man were charged with odometer tampering, the Justice Department announced today.

The Justice Department today announced that Morgan Stanley will pay a $2

From : Communities>>Regulatory Open Forum
Hello,  I can see many unapproved combinations of Minoxidil as topical solution like minoxidil+ Azelaic Acid; Minoxidil + Finasteride; Minoxdil+ niacin+retinol+caffeine that are available online for sale in US but these drug products are not approved by FDA as visble from USFDA website.  Can anyone explain that is there any mechanism or guideline to allows to sell such unapproved drug products online in US and also in EU? Or is this totally illegal practice?  Thanks Ankur RAC

From : Communities>>Regulatory Open Forum
Hi, Ankur - Some may be "legal," others not. It's a big industry, and it is fair to be cynical. Combination products for sale that have not been approved-as the combination-by FDA are just that, unapproved drugs. I assume you checked for the approval status in FDA's "Orange Book" (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm). Even if both active pharmaceutical ingredients in a 2-drug mixture were approved separately on their own, it does not mean the combined product is approved for [More]

From : Communities>>Regulatory Open Forum
These are all unapproved new drugs. Many people who have very limited knowledge of our OTC drug system, assume that if it is sold OTC, it is a monographed drug and they can change the formulation. They do not know that there are two types of OTC drugs allowed-compliance with a monograph or NDA. Minoxidil is one and chlorhexidine antiseptic wash is another. ------------------------------ David Steinberg,FRAPS President Steinberg & Associates, Inc. Pompton Plains NJ USA 609-902-8860 -------------- [More]

From : Communities>>Regulatory Open Forum
The only  possible way I can see any of these products being legally marketed in the US without going the OTC NDA route would be if the ingredients  other than Minoxidil are considered "inactive" and have some purpose (other than their active ingredient purposes) in the formulation.  That said, this might work for the last combination in your listing because all of these can and are often used in OTC products as inactive ingredients with understood and current reasons for existing in a formulation [More]

From : Communities>>Regulatory Open Forum
These types of products and combinations you mention are all unapproved drugs and unapproved combinations.  Unless the specific combination is approved or listed in an OTC monograph, it is a new drug and requires a NDA to market it.  Minoxidil is a Rx to OTC switch product so it requires a NDA or ANDA to market this drug in the US, even as a OTC drug.  Thus any combination with minoxidil is a new drug. In the past the FDA has also specifically stated that combining different types of products (drug [More]

Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.

To read the whole article click on the headline

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.

With social distancing in full effect, families have not only found themselves with a lot more time together, but a lot more time in front of their screens.

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading