A Delaware company pleaded guilty today in federal court in the Eastern District of Louisiana to negligently discharging oil into the bayous of Jefferson Parish, Louisiana, the Department of Justice announced.

F. Harvey Whittemore, 55, of Reno, Nevada, was charged with one count of making excessive campaign contributions, one count of making contributions in the name of others and two counts of making a false statement to a federal agency.

The EU and the U.S., at the EU-U.S. Justice and Home Affairs Ministerial Meeting attended by Attorney General Eric Holder today, have agreed to enhance efforts against child sexual abuse online. Such abuse includes the distribution and trade of child pornography via the Internet, and the resulting, continuing harm to the victims depicted.

The Department of Justice announced today that the United States has entered into a comprehensive, cooperative consent decree with the city of New Orleans to resolve allegations of unlawful police misconduct by the New Orleans Police Department.

The Justice Department announced today that it has reached a settlement with the city of Woodlake, Calif., to resolve allegations that the city engaged in a pattern or practice of discrimination against people with disabilities by requiring applicants for job vacancies to undergo unlawful pre-employment medical examinations before receiving an offer of employment, in violation of the Americans with Disabilities Act (ADA).

Peter Borgia Jr., 22, was sentenced by U.S. District Judge Leonie M. Brinkema.

Cedyco Corporation, headquartered in Houston, was sentenced today in federal court in the Eastern District of Louisiana.

An Oregon man and a Virginia man were sentenced to prison for their role in a conspiracy to advertise, distribute and possess child pornography.

Andrew Strempler, a Canadian citizen, pleaded guilty today in the Southern District of Florida for his role in a scheme to defraud consumers purchasing pharmaceuticals online, the Justice Department announced. Strempler faces up to five years in prison, a forfeiture of $300,000, a fine and restitution.

Beatrix Boka, 34, of Hungary, pleaded guilty today before U.S. District Judge Aleta A. Trauger in the Middle District of Tennessee to one count of conspiracy to commit bank and wire fraud.

Attorney General Eric Holder and European Union (EU) Commissioner for Home Affairs Cecilia Malmström will launch the Global Alliance Against Child Sexual Abuse Online at a ministerial conference tomorrow, Dec. 5, 2012, in Brussels.

Two Wisconsin men and a Missouri man were sentenced to prison for their role in a conspiracy to advertise, distribute and possess child pornography.

"Despite the uncertain challenges we face, and the many responsibilities before us, I’m confident that today’s session will afford a unique opportunity to strengthen our shared commitment to this work," said Attorney General Holder.

The U.S. District Court for the District of Columbia issued a consent order of forfeiture today ordering the civil forfeiture of $6,976,924 traced to international money laundering of the proceeds from an offshore Internet gambling operation that illegally targeted U.S. residents.

Amazon.com; Leon Max Inc., d/b/a Max Studio; Macy’s Inc.; and Sears, Roebuck and Co., Kmart Corporation and Kmart.com (collectively, Sears) have agreed to settle civil lawsuits concerning alleged violations of the Textile Fiber Product Identification Act and the Federal Trade Commission Act.

A Canadian citizen was sentenced to 48 months in prison today for his role in a scheme to defraud consumers purchasing pharmaceuticals online, the Justice Department announced. Andrew J. Strempler was also ordered to pay a forfeiture of $300,000, a fine of $25,000 and restitution.

Today the United States filed a civil action against ATP Oil &s Bureau of Safety and Environmental Enforcement (BSEE) and the U.S. Environmental Protection Agency (EPA). The complaint addresses the defendants’ alleged unlawful discharges of oil and unpermitted chemical dispersants from the defendants’ floating oil and gas production platform, the ATP Innovator, into the Gulf of Mexico.

Hungarian nationals Beatrix Boka and Aleksandar Kunkin were sentenced today to serve 36 months and 48 months in prison, respectively, for their roles in moving approximately $550,000 in illicit proceeds derived from an international online marketplace fraud scheme.

Norman Teltow, owner of Gold Metal Paint Co. LLC (GMP), pleaded guilty late yesterday in Denver to a criminal information charging him with illegally treating hazardous waste at the company’s facility.

Thirty-four individuals and 23 entities have been indicted and accused of operating an illegal sports bookmaking business that solicited more than $1 billion in illegal bets.

A Pennsylvania man was sentenced today to serve 12 years in prison for coercing and enticing a minor and possessing child pornography.

Benjamin Franklin Pass, 60, and P&s Environment and Natural Resources Division and the U.S. Attorney’s Office for the Eastern District of North Carolina. The defendants admitted to, among other things, the unlawful handling of a toxic substance that resulted in widespread contamination.

A pest control services company and its owner have been charged today in the U.S. District Court for the Middle District of Georgia with conspiracy, unlawful use of pesticides, false statements, falsification of records and mail fraud, announced Robert G. Dreher, Acting Assistant Attorney General of the Justice Department’s Environment and Natural Resources Division and Michael J. Moore, U.S. Attorney for the Middle District of Georgia.

Donald John Sachtleben, a former FBI bomb technician who later worked as a government contractor for the agency, has filed a petition to plead guilty to newly filed charges of unlawfully disclosing national defense information relating to a disrupted terrorist plot. Sachtleben previously had filed a petition to plead guilty to charges of possessing and distributing child pornography resulting from a separate investigation.

The Justice Department today announced an enhanced online resource designed to support American victims of overseas terrorism.

The Department of Justice announced today that a federal grand jury in the Middle District of Alabama has returned an indictment against J. Keith McCray, a criminal investigator with the Macon County, Ala., Sheriff’s Office for violating the rights of a man he unlawfully seized and assaulted.

Stanley Electric Co. Ltd., a Tokyo-based company, has agreed to plead guilty and to pay a $1.44 million criminal fine for its participation in a conspiracy to fix prices of lamp ballasts installed in cars sold in the United States and elsewhere.

The U.S. Department of Justice today hosted a meeting to launch a joint task force between the United Kingdom and the United States to counter online child exploitation

An unlicensed nurse who fled after being charged in 2008 and was captured this year was sentenced today to serve 108 months in prison.

The Department of Justice today submitted to the court a proposed remedy to address Bazaarvoice Inc.’s unlawful acquisition of PowerReviews Inc., following the Jan. 8, 2014, U.S. District Court for the Northern District of California finding that Bazaarvoice violated Section 7 of the Clayton Act when it acquired PowerReviews, its closest and only serious competitor.

Steven A. Murray, 54, of Pelham, Ala., and his company, Bio-Tech Management Inc., pleaded guilty today in federal court in Macon, Ga., to charges of conspiracy, unlawful use of pesticides, false statements and mail fraud in connection with the misapplication of pesticides in Georgia nursing homes.

A federal jury in Detroit today convicted a physical therapist, physical therapy assistant and unlicensed doctor for their participation in a nearly $15 million Medicare fraud scheme.

A Phoenix man convicted after a jury trial last December of conspiracy and racketeering offenses for his involvement in a sophisticated cybercrime organization was sentenced today to serve 20 years in prison.

Benjamin Franklin Pass, 61, and P&W Waste Oil Services Inc. (P&W), of Leland, North Carolina were sentenced today in federal court in Raleigh, North Carolina. Pass was sentenced to 42 months in prison and ordered to pay restitution in the amount of $21,373,143.38 for clean-up costs associated with the environmental contamination at his business and an additional $538,857 to the Internal Revenue Service (IRS) for federal income taxes he failed to pay between 2002 and 2011

An unlicensed trader who solicited $500,000 from undercover FBI agents to invest in a fraudulent high yield investment program pleaded guilty today in federal court in Los Angeles

Adam Michael Webber, of Salt Lake County, Utah, was indicted on Friday by a federal grand jury in the District of Utah, the Justice Department announced. The indictment, which was made public today, charges Webber with one count of dealing in firearms without a license, one count of smuggling goods from the United States and six counts of filing false tax returns

The Justice Department announced today that under its settlements with five of the nation’s largest mortgage servicers, 952 service members and their co-borrowers are eligible to receive over $123 million for non-judicial foreclosures that violated the Servicemembers Civil Relief Act (SCRA)

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

Outside influences have shown strong correlations with what lives inside our bodies, and researchers are just beginning to understand how these environmental factors may affect the makeup of the gut microbiome.

NutraIngredients is pleased to announce the shortlisted finalists for the 2020 edition of the NutraIngredients Awards ... with the winners to be announced in the first online awards ceremony next week (May 13th).

From : Communities>>Regulatory Open Forum
Great! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------

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
Annie: Thank you for sharing this news.  I am curious whether the Board considers this a limited exception or a potential new normal option going forward? Scott ------------------------------ Scott Bishop Houston TX United States ------------------------------ ------------------------------------------- Original Message: Sent: 04-May-2020 08:50 From: Annie O'Brien Subject: New: Take the RAC Exams Online this Summer! The RAC board has been working hard to find solutions offering more flexibility [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]

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

Posted by Roger Bate Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad &ndash [...]

The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak.