nat Justice Department Obtains $80,000 Settlement in Housing Discrimination Lawsuit Against California Landlord By www.justice.gov Published On :: Fri, 29 Aug 2014 14:55:56 EDT The Justice Department today announced an agreement with the owners and operators of Woodland Garden Apartments in Fremont, California, to settle allegations of discrimination against families with children. Under the consent order, which must still be approved by the U.S. District Court for the Northern District of California, the defendants are required to pay $77,500 to the victims of their discrimination and an additional $2,500 to the government as a civil penalty Full Article OPA Press Releases
nat Remarks by Associate Attorney General Tony West at the Juvenile Justice Coordinating Council By www.justice.gov Published On :: Mon, 28 Jul 2014 10:20:23 EDT "...we're here because 60,000 young people are still confined in juvenile detention and correction facilities on any given day and when they are released they will need support to successfully make that transition to productive adulthood and stable lives." Full Article Speech
nat Justice Department Files Lawsuit Alleging Sex Discrimination Against the Commonwealth of Pennsylvania and the Pennsylvania State Police By www.justice.gov Published On :: Fri, 29 Aug 2014 10:05:12 EDT The Justice Department announced the filing of a lawsuit today against the Commonwealth of Pennsylvania and the Pennsylvania State Police, alleging that the defendants are engaged in a pattern or practice of employment discrimination against women in violation of Title VII of the Civil Rights Act of 1964. Specifically, the lawsuit challenges the state police’s use of two physical fitness tests to screen and select entry-level state troopers Full Article OPA Press Releases
nat Remarks by Assistant Attorney General John P. Carlin on Cyber National Security Threats at Carnegie Mellon University By www.justice.gov Published On :: Wed, 30 Jul 2014 14:17:47 EDT This week marks a busy time for national security law. There is a lot going on in the world, all of which we are tracking closely. But I’m going to focus today on the threats associated with national security cyber issues. Full Article Speech
nat Department of Justice and the International Association of Chiefs of Police Release Groundbreaking Model Policy By www.justice.gov Published On :: Thu, 28 Aug 2014 16:15:59 EDT The Department of Justice’s Office of Justice Programs (OJP), in partnership with the International Association of Chiefs of Police (IACP), today released a seminal model policy regarding police interaction with children who are impacted when a parent is arrested and law enforcement carries out its investigative and arrest responsibilities. Reflecting the collective input of a wide range of subject-matter experts and stakeholders, and understanding that interactions between children and law enforcement create lasting impressions, the resulting model policy, Safeguarding Children of Arrested Parents , provides strategies for law enforcement to improve their procedures and positively impact the communities they serve Full Article OPA Press Releases
nat Louisiana State Bond Commission Agrees to Settlement to Resolve Housing Discrimination Lawsuit By www.justice.gov Published On :: Thu, 28 Aug 2014 16:07:34 EDT The Justice Department announced today that the United States District Court for the Eastern District of Louisiana has approved its settlement with the Louisiana State Bond Commission resolving the department’s housing discrimination lawsuit. The lawsuit alleged that the commission violated the Fair Housing Act and the Americans with Disabilities Act by adopting a moratorium on affordable housing financing in 2009. The moratorium blocked financing for a proposed 40-unit affordable housing project known as the “Esplanade.” Twenty of these units would provide permanent supportive housing to persons with disabilities Full Article OPA Press Releases
nat Justice Department Announces $1.5 Million Paid to Victims of Discrimination by Quiktrip Corporation By www.justice.gov Published On :: Thu, 28 Aug 2014 16:06:00 EDT The Justice Department today announced the payment of more than $1.5 million in damages under a consent decree previously reached with QuikTrip Corporation. The payments were made by QuikTrip to compensate 47 individuals with disabilities who experienced discrimination at QuikTrip gas stations and convenience stores across the country, in violation of Title III of the Americans with Disabilities Act (ADA). Full Article OPA Press Releases
nat Attorney General Eric Holder Speaks at the National Association of Criminal Defense Lawyers 57th Annual Meeting and 13th State Criminal Justice Network Conference By www.justice.gov Published On :: Fri, 1 Aug 2014 10:22:48 EDT "This morning, as I look around this crowd of passionate professionals and dedicated public servants, I cannot help but feel confident in our ability to do just that; to develop smart solutions to the toughest problems we face; to protect the rights of everyone in this country, no matter their salary or their skin color; and to further enshrine the ideals of American justice into the annals of American law." Full Article Speech
nat Six Alleged Members of the Almighty Imperial Gangsters Nation Gang Indicted By www.justice.gov Published On :: Thu, 28 Aug 2014 15:28:38 EDT Five alleged members of the violent Almighty Imperial Gangsters Nation gang have been indicted by a federal grand jury in the Southern District of Florida for their roles in multiple murders. A sixth alleged gang member was indicted for unlawfully possessing a firearm Full Article OPA Press Releases
nat Justice Department Settles Immigration-Related Employment Discrimination Claim Against New York Nursing Home By www.justice.gov Published On :: Thu, 28 Aug 2014 15:25:00 EDT The Justice Department announced today that it reached an agreement with Isabella Geriatric Center (IGC), a nursing home located in New York City, resolving a claim that IGC engaged in a pattern or practice of citizenship discrimination during the employment eligibility reverification process in violation of the Immigration and Nationality Act (INA). Full Article OPA Press Releases
nat Associate Attorney General Tony West Delivers Remarks at the Progressive National Baptist Convention By www.justice.gov Published On :: Tue, 5 Aug 2014 11:43:35 EDT "Because if a government of, by and for the people means anything at all, it means that a ballot has the power to give equal voice to the high and the low; the weak and the strong; those at the bottom as well as the top. It means that in the polling place, the line is just as long for the richest among us as it is for those who often work the hardest but have the least." Full Article Speech
nat Justice Department Settles Citizenship Status Discrimination Claim Against Travel Management Company By www.justice.gov Published On :: Thu, 28 Aug 2014 15:16:28 EDT The Justice Department reached an agreement today with Travel Management Company, a private airplane charter company based in Elkhart, Indiana, resolving claims that the company engaged in citizenship status discrimination in violation of the Immigration and Nationality Act (INA). Full Article OPA Press Releases
nat Justice Department Reaches Settlement with Fifth Third Mortgage Company to Resolve Allegations of Discrimination Against Recipients of Disability Income By www.justice.gov Published On :: Thu, 28 Aug 2014 15:15:06 EDT The Department of Justice filed a settlement today with Fifth Third Mortgage Company to resolve allegations that it engaged in a pattern or practice of discrimination on the basis of disability and receipt of public assistance in violation of the Fair Housing Act (FHA) and the Equal Credit Opportunity Act (ECOA). Under the settlement, Fifth Third has agreed to maintain revised policies, conduct employee training and pay over $1.5 million to compensate victims Full Article OPA Press Releases
nat Russian National Arraigned on Indictment for Distributing Credit Card Data Belonging to Thousands of Card Holders By www.justice.gov Published On :: Thu, 28 Aug 2014 14:57:29 EDT A Russian national indicted for hacking into point of sale systems at retailers throughout the United States and operating websites that distributed credit card data of thousands of credit card holders appeared today for arraignment in U.S. federal court, announced U.S. Attorney Jenny A. Durkan of the Western District of Washington and Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division Full Article OPA Press Releases
nat Deputy Assistant Attorney General Mark Kappelhoff Delivers Opening Statement at the Convention on the Elimination of Racial Discrimination By www.justice.gov Published On :: Wed, 13 Aug 2014 09:53:56 EDT Mr. Chairperson, distinguished Members of the committee, and representatives of civil society. My name is Mark Kappelhoff and I serve as a Deputy Assistant Attorney General in the Civil Rights Division of the U.S. Department of Justice. It is an honor to be a member of the U.S. delegation and to share with you some of the Justice Department’s work to address racial discrimination and to fulfill our obligations under the convention. Full Article Speech
nat U.S. Attorney Loretta Lynch for the Eastern District of New York Delivers Remarks at the Convention on the Elimination of Racial Discrimination By www.justice.gov Published On :: Wed, 13 Aug 2014 11:24:10 EDT Mr. Chairperson, distinguished members of the committee, and representatives of civil society, it is an honor to be a part of the U.S. delegation and share some of the highlights of the Department of Justice’s efforts to eliminate racial discrimination and uphold human rights in the area of criminal justice. Full Article Speech
nat Justice Department Obtains $100,000 Settlement in Housing Discrimination Lawsuit Against Cleveland Landlord By www.justice.gov Published On :: Thu, 28 Aug 2014 14:29:47 EDT The Justice Department announced today that the manager and owner of the Linden House Apartments in Cleveland have agreed to pay $100,000 to resolve allegations that they refused to rent to individuals because the individuals had children . The settlement must still be approved by U.S. District Judge Solomon Oliver Jr Full Article OPA Press Releases
nat Justice Department Settles Immigration-Related Discrimination Claim Against Staffing Agency By www.justice.gov Published On :: Thu, 28 Aug 2014 14:20:45 EDT The Justice Department reached an agreement today with Real Time Staffing Services LLC, doing business as Select Staffing, a company based in Santa Barbara, California. The settlement resolves the department’s claims that Select Staffing discriminated against work-authorized non-U.S. citizens in violation of the Immigration and Nationality Act (INA). Full Article OPA Press Releases
nat Grand Rapids Landlords to Pay $550,000 and Terminate Manager’s Responsibilities to Settle Sexual Harassment Lawsuit Filed by Justice Department By www.justice.gov Published On :: Thu, 28 Aug 2014 14:06:01 EDT The Justice Department announced today that the owners and operators of the Alger Meadows Apartments in Grand Rapids, Michigan, have agreed to pay $550,000 in damages and civil penalties and to terminate property manager Dale VanderVennen’s role in managing the complex to settle a lawsuit alleging that VanderVennen sexually harassed female tenants in violation of the Fair Housing Act (FHA). Full Article OPA Press Releases
nat Justice Department Reaches Agreement with the City of Baltimore to Prevent Disability Discrimination By www.justice.gov Published On :: Thu, 28 Aug 2014 13:57:47 EDT The Justice Department today announced that it has reached an agreement with the city of Baltimore, Maryland, to end hiring practices that discriminate against people with disabilities. The agreement, filed as a consent decree along with a complaint in the U.S. District Court for the District of Maryland, resolves allegations by the department that the city engaged in a pattern or practice of discrimination under the Americans with Disabilities Act (ADA). Title I of the ADA prohibits employers from discriminating against individuals on the basis of disability in various aspects of employment, including hiring Full Article OPA Press Releases
nat Eight Alleged Members and Associates of the Two Six Nation Street Gang Indicted for Racketeering Conspiracy By www.justice.gov Published On :: Thu, 28 Aug 2014 13:36:42 EDT Four members of the Two Six Nation street gang and four of their associates have been indicted for their roles in a racketeering conspiracy spanning more than 20 years, as well as murder and drug trafficking charges Full Article OPA Press Releases
nat Massillon, Ohio Landlords Agree to $850,000 Settlement to Resolve Housing Discrimination Lawsuits By www.justice.gov Published On :: Thu, 28 Aug 2014 13:30:58 EDT The Justice Department announced today that Massillon, Ohio landlords John and Mary Ruth have agreed to pay $850,000 to settle lawsuits filed by the Justice Department and other parties alleging that the Ruths discriminated on the basis of race and familial status at properties they formerly owned in Massillon. The settlement must still be approved by United States District Judge John R. Adams in the Northern District of Ohio Full Article OPA Press Releases
nat Former Iowa State Senator Pleads Guilty to Concealing Federal Campaign Expenditures By www.justice.gov Published On :: Thu, 28 Aug 2014 13:08:16 EDT A former Iowa State Senator pleaded guilty today to concealing payments he received from a presidential campaign in exchange for switching his support and services from one candidate to another and to obstructing a subsequent investigation into his conduct. Full Article OPA Press Releases
nat Justice Department Files Lawsuit Against Louisiana Crane Company Alleging Discrimination Against Work-authorized Immigrants By www.justice.gov Published On :: Fri, 29 Aug 2014 13:04:01 EDT The Justice Department announced today the filing of a lawsuit with the Executive Office for Immigration Review against Louisiana Crane Company LLC (Louisiana Crane), which is headquartered in Eunice, Louisiana. Full Article OPA Press Releases
nat Justice Department Settles Immigration-Related Employment Discrimination Claim Against a Restaurant Management Company By www.justice.gov Published On :: Tue, 2 Sep 2014 09:50:33 EDT The Justice Department announced today that it reached an agreement with Culinaire International, a catering and restaurant management company headquartered in Houston, Texas, resolving a claim that Culinaire engaged in citizenship discrimination during the employment eligibility reverification process in violation of the Immigration and Nationality Act (INA). Full Article OPA Press Releases
nat Trans Energy Inc. to Restore Streams and Wetland Damaged by Natural Gas Extraction Activities in West Virginia By www.justice.gov Published On :: Tue, 2 Sep 2014 16:49:34 EDT The Department of Justice, the U.S. Environmental Protection Agency (EPA) and the West Virginia Department of Environmental Protection (WVDEP) today announced a settlement with Trans Energy Inc., requiring the oil and gas company to restore portions of streams and wetlands at 15 sites in West Virginia that were polluted by the company’s unauthorized discharge of dredge or fill material. Trans Energy will pay a penalty of $3 million to be divided equally between the federal government and the WVDEP. The Clean Water Act requires a company to obtain a permit from EPA and the U.S. Army Corps of Engineers prior to discharging dredge or fill material into wetlands, rivers, streams and other waters of the United States. Full Article OPA Press Releases
nat United States Settles with Costco to Cut Ozone-Depleting and Greenhouse Gas Refrigerant Emissions Nationwide By www.justice.gov Published On :: Wed, 3 Sep 2014 11:58:06 EDT Costco Wholesale Corporation, one of the nation’s largest retailers, has agreed to cut its emissions of ozone-depleting and greenhouse gases from leaking refrigeration equipment at more than half of its stores nationwide. Full Article OPA Press Releases
nat Colombian National Pleads Guilty to Kidnapping and Murder of DEA Agent Terry Watson By www.justice.gov Published On :: Wed, 3 Sep 2014 18:36:17 EDT A Colombian man extradited to the Eastern District of Virginia pleaded guilty today for his involvement in the kidnapping and murder of Drug Enforcement Administration (DEA) Special Agent James Terry Watson in Bogotá, Colombia, on June 20, 2013. Full Article OPA Press Releases
nat New England Compounding Center Supervising Pharmacist Arrested at Logan International Airport By www.justice.gov Published On :: Thu, 4 Sep 2014 11:34:18 EDT A Canton, Massachusetts, man was arrested today at Boston's Logan International Airport in connection with the ongoing criminal investigation of New England Compounding Center by the Justice Department’s Civil Division and U.S. Attorney’s Office for the District of Massachusetts. Full Article OPA Press Releases
nat Justice Department Participates in Child Cyber Safety Night at Nationals Park, Saturday, September 6th By www.justice.gov Published On :: Fri, 5 Sep 2014 14:13:32 EDT Child Cyber Safety Night at the Ballpark is the latest effort by the Justice Department and its law enforcement and community partners to encourage parents to speak with their children about online and cell phone safety and provide prevention materials. Full Article OPA Press Releases
nat Justice Department Files Fair Housing Lawsuit Against Kent State University for Discrimination Against Students with Disabilities in University Housing By www.justice.gov Published On :: Mon, 8 Sep 2014 18:12:14 EDT The Justice Department today filed a lawsuit against the Kent State University, the Kent State University Board of Trustees and university officials for violating the Fair Housing Act by discriminating against students with disabilities in student housing. Full Article OPA Press Releases
nat Justice Department Settles Religious Discrimination Lawsuit Against School District of Philadelphia By www.justice.gov Published On :: Mon, 8 Sep 2014 18:09:18 EDT The Department of Justice announced today that it has entered into a settlement agreement with the School District of Philadelphia that resolves a religious accommodations lawsuit filed in March 2014. In its lawsuit, the United States alleged that the school district violated Title VII of the Civil Rights Act of 1964 (Title VII) by failing to accommodate the religious beliefs, observances and/or practices of Siddiq Abu-Bakr, a school police officer who is Muslim, and similarly-situated employees who maintain a beard longer than one-quarter inch for religious purposes. Full Article OPA Press Releases
nat Remarks by Assistant Attorney General Karol Mason Before the Senate Committee on Homeland Security and Governmental Affairs By www.justice.gov Published On :: Tue, 9 Sep 2014 11:53:06 EDT Chairman Carper, Ranking Member Coburn and distinguished members of the committee, thank you for inviting me to speak with you today about the Department of Justice’s role in supporting state, local and tribal law enforcement agencies. Full Article Speech
nat Arvada Woman Pleads Guilty to Conspiracy to Provide Material Support to a Designated Foreign Terrorist Organization By www.justice.gov Published On :: Wed, 10 Sep 2014 13:50:21 EDT Shannon Conley, age 19, of Arvada, Colorado, pleaded guilty this morning before U.S. District Court Judge Raymond P. Moore to one count of conspiracy to provide material support to a designated foreign terrorist organization, U.S. Attorney John Walsh for the District of Colorado and Special Agent in Charge Thomas Ravenelle of the FBI Denver Division announced. Conley is scheduled to be sentenced by Judge Moore on January 23, 2015. The defendant appeared at the change of plea hearing in custody, and was remanded at its conclusion. Full Article OPA Press Releases
nat Statement by the U.S. Department of Justice and the Office of the Director of National Intelligence on the Declassification of Documents Related to the Protect America Act Litigation By www.justice.gov Published On :: Thu, 11 Sep 2014 18:58:53 EDT On January 15, 2009, the U.S. Foreign Intelligence Surveillance Court of Review (FISC-R) published an unclassified version of its opinion in In Re: Directives Pursuant to Section 105B of the Foreign Intelligence Surveillance Act, 551 F.3d 1004 (Foreign Intel. Surv. Ct. Rev. 2008). The classified version of the opinion was issued on August 22, 2008, following a challenge by Yahoo! Inc. (Yahoo!) to directives issued under the Protect America Act of 2007 (PAA). Today, following a renewed declassification review, the Executive Branch is publicly releasing various documents from this litigation, including legal briefs and additional sections of the 2008 FISC-R opinion, with appropriate redactions to protect national security information. These documents are available at the website of the Office of the Director of National Intelligence (ODNI), www.dni.gov; and ODNI’s public website dedicated to fostering greater public visibility into the intelligence activities of the U.S. Government, IContheRecord.tumblr.com. A summary of the underlying litigation follows. Full Article OPA Press Releases
nat Remarks by Attorney General Eric Holder at the Hispanic National Bar Association 39th Annual Convention By www.justice.gov Published On :: Fri, 12 Sep 2014 12:45:05 EDT Buenas tardes. Muchas gracias por sus emotivas palabras y su calurosa bienvenida. It’s a privilege to help welcome the Hispanic National Bar Association to our nation’s capital for your 39th Annual Convention. And it’s a great pleasure, as always, to be in such distinguished company. Full Article Speech
nat Hawaii Man Sentenced to 87 Months Imprisonment for Communicating Classified National Defense Information to Unauthorized Person By www.justice.gov Published On :: Wed, 17 Sep 2014 17:50:08 EDT Benjamin Pierce Bishop, 60, a former Honolulu, Hawaii, civilian defense contractor and retired lieutenant colonel in the U.S. Army, was sentenced today by U.S. District Judge Leslie E. Kobayashi to serve 87 months imprisonment and three years’ supervised release for willfully communicating classified national defense information to a person not authorized to receive it and unlawfully retaining classified national defense information at his home. Full Article OPA Press Releases
nat Justice Department Announces National Effort to Build Trust Between Law Enforcement and the Communities They Serve By www.justice.gov Published On :: Thu, 18 Sep 2014 11:01:37 EDT Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice. Full Article OPA Press Releases
nat Former California Attorney Pleads Guilty in International Investment Fraud Scheme By www.justice.gov Published On :: Wed, 25 Nov 2015 08:45:26 EST A Las Vegas man pleaded guilty today to conspiracy for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors Full Article OPA Press Releases
nat Executives of Swiss and Las Vegas Companies Convicted in International Investment Fraud Scheme By www.justice.gov Published On :: Thu, 10 Dec 2015 08:45:28 EST A federal jury in Las Vegas convicted two men of conspiracy, wire fraud and securities fraud yesterday for their roles in an approximately $10 million international investment fraud scheme involving numerous victims Full Article OPA Press Releases
nat Justice Department Reaches $470 Million Joint State-Federal Settlement with HSBC to Address Mortgage Loan Origination, Servicing and Foreclosure Abuses By www.justice.gov Published On :: Wed, 17 Feb 2016 19:56:24 EST The Justice Department, the Department of Housing and Urban Development (HUD) and the Consumer Financial Protection Bureau, along with 49 state attorneys general and the District of Columbia’s attorney general, have reached a $470 million agreement with HSBC Bank USA NA and its affiliates (collectively, HSBC) to address mortgage origination, servicing and foreclosure abuses Full Article OPA Press Releases
nat Former California Attorney Sentenced to 60 Months for His Role in International Investment Fraud Scheme By www.justice.gov Published On :: Tue, 23 Feb 2016 20:45:29 EST A Las Vegas man was sentenced today to 60 months in prison for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors Full Article OPA Press Releases
nat Toano Man Pleads Guilty to Impersonating a Federal Agent By www.justice.gov Published On :: Fri, 24 Jun 2016 20:45:27 EDT NEWPORT NEWS, Va Full Article OPA Press Releases
nat New FDA guidance on alternate approaches in premarket notification for Class II medical devices By feedproxy.google.com Published On :: Fri, 20 Dec 2019 14:09:57 +0000 By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket … Continue reading » Full Article Cato Research FDA FDA Regulatory Guidances Medical Device FDA Guidances medical devices
nat RedHill Biopharma Provides Update On Compassionate Use Program With Opaganib By www.rttnews.com Published On :: Mon, 27 Apr 2020 11:37:16 GMT Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) on Monday provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1, in patients with confirmed SARS-CoV-2 infection (the cause of COVID-19) in Israel. Full Article
nat Care Coordination Strategies for Patients Can Improve Substance Use Disorder Outcomes By feedproxy.google.com Published On :: Thu, 23 Apr 2020 14:17:00 -0400 Care coordination is considered a hallmark of patient-centered treatment and has been shown to improve health outcomes and patient satisfaction as well as reduce costs. Defined as organizing patient care activities and sharing information among all participants concerned with an individual’s treatment plan in order to achieve safer and more effective results, care coordination is increasingly... Full Article
nat Organic Trade Association and The Organic Center Applaud Senate Bill, Organic Agriculture Research By feedproxy.google.com Published On :: Thu, 08 Feb 2018 22:38:00 GMT The Organic Trade Association and The Organic Center on Thursday applauded Senators Bob Casey (D-PA) and Susan Collins (R-ME) for introducing The Organic Agriculture Research Act of 2018. Full Article
nat National Institutes of Health Announces NIAGEN® Shows Improved Cognitive and Physical Function By feedproxy.google.com Published On :: Fri, 09 Feb 2018 15:39:00 GMT ChromaDex Corp. announced NIAGEN® nicotinamide riboside prevented neurological damage and improved cognitive and physical function in a new mouse model of Alzheimer’s disease. Full Article
nat Online sale of unapproved combinations of Minoxidil as topical solution By connect.raps.org Published On :: Thu, 07 May 2020 23:07:00 -0400 From : Communities>>Regulatory Open ForumHello, 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 Full Article Discussion
nat RE: Online sale of unapproved combinations of Minoxidil as topical solution By connect.raps.org Published On :: Fri, 08 May 2020 04:15:00 -0400 From : Communities>>Regulatory Open ForumHi, 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] Full Article Discussion