A federal indictment returned under seal in June 2013 and unsealed today charges six foreign nationals, including a Ukrainian businessman and a government official in India, with participating in an alleged international racketeering conspiracy.

Edward N. Levine, 63, of Mill Valley, Calif., and Lumsden W. Quan, 46, of San Francisco, were indicted by a federal grand jury in Las Vegas today for the illegal sale of two horns from an endangered black rhinoceros.

A Dominican national was sentenced today for his role in trafficking the identities and corresponding identity documents of Puerto Rican U.S. citizens.

Attorney General Eric Holder and Secretary Arne Duncan today announced updated guidance to assist public elementary and secondary schools to ensure enrollment processes are consistent with the law and fulfill their obligation to provide all children – no matter their background – equal access to an education.

Especially as we approach the 60th anniversary of the Supreme Court’s decision in Brown v. Board of Education, in which Chief Justice Earl Warren called education “a right which must be made available to all on equal terms,” it is imperative that we do everything in our power to end policies or practices that deny this right to those who are constitutionally entitled to it.

Jordan-based Arab Ship Management Ltd. pleaded guilty today in federal court in Wilmington, Delaware, to one count of violating the Act to Prevent Pollution from Ships, the Justice Department and the U.S. Coast Guard announced.

Three defendants were arrested today on charges of providing material support to al-Shabaab, a designated foreign terrorist organization that is conducting a violent insurgency campaign in Somalia

Ivan Soto-Barraza, who is charged with the first degree murder of United States Border Patrol Agent Brian Terry, was extradited to the United States from Mexico today, announced Attorney General Eric Holder and U.S. Attorney Laura E. Duffy of the Southern District of California

Rosario Rafael Burboa-Alvarez was indicted by a federal grand jury in Tucson yesterday, becoming the seventh man charged in connection with the murder of U.S. Border Patrol Agent Brian Terry, announced Attorney General Eric Holder and U.S. Attorney Laura E. Duffy of the Southern District of California

Wasseem Shamoun pleaded guilty to conspiracy to commit bank fraud in the U.S. District Court for the Eastern District of Michigan today, announced the Justice Department and Internal Revenue Service (IRS). On July 16, 2013, a superseding indictment was unsealed charging Shamoun and six other individuals with conspiracy to commit bank fraud, multiple counts of bank fraud and other fraud charges relating to a mortgage loan scheme

Ahmad Ibrahim Al-Ahmad made his initial appearance today in federal court in Phoenix, Arizona, on federal terrorism offenses, announced John P. Carlin, Assistant Attorney General for National Security.

Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”), and Philip R

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 …

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By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

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Another leading athlete has joined Arla Foods Ingredients’ growing number of brand ambassadors for Lacprodan® HYDRO.365.

The Council for Responsible Nutrition announced the launch of a consumer education initiative designed to raise awareness of Selective Androgen Receptor Modulators, a dangerous class of ingredients.

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

UPDATE: The guidance mentioned below was released. Here's the link.

The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:

• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers 

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

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

By Rachael E. Hunt —

Lucky Devil's dancers put on a show in the parking lot when customers order takeout.

For millions of Americans, working at home isn't an option. NBC News identified seven occupations in which employees are at especially high risk of COVID-19.

Yokogawa Electric Corporation (TOKYO: 6841) announces that on March 20, 2020, it completed the acquisition of all shares in Denmark-based Grazper Technologies ApS (Grazper), as mutually agreed. Grazper has developed advanced artificial intelligence (AI) technologies for analyzing images, and Yokogawa aims to leverage these technologies within its various existing businesses and to develop new industrial AI solutions.

Jan 8, 2020

The smoke is still clearing from the drone strike that killed Quds Force commander Qassem Suleimani, and from the Iranian retaliation against U.S. bases in Iraq, and any conclusions have to be tentative ones. But the history of U.S.-Iran conflict points to a narrow, and possibly dangerous, set of choices ahead.

Campillo-Meseguer, María-José and Galiano-Martínez, Antonio and Gómez-Hernández, José-Antonio and Hidalgo-Pérez, Antonio and López Aniorte, María-del-Carmen and Martínez-Navarro, Emilio and Molina-Molina, José and Mayor-Balsas, José-Manuel and Ros-Media, José Luis and Oliva-Palazón, Elena and Reverte-Martínez, Francisco-Manuel and Baeza-Hernández, María-José . Educar para la transparencia y una ciudadanía informada: diseño, aplicación y evaluación del programa IRIS para alumnado de Bachillerato de la Región de Murcia (España)., 2020 In: Competencias en Información y Políticas para Educación Superior: Estudios Hispano-Brasileños, volumen 1. Universidad Complutense de Madrid, pp. 123-138. [Book chapter]

Jan 28, 2020

In the unintuitive world of nuclear weapons strategy, it’s often difficult to identify which decisions can serve to decrease the risk of a devastating nuclear conflict and which might instead increase it. Such complexity stems from the very foundation of the field: Nuclear weapons are widely seen as bombs built never to be used. Historically, granular—even seemingly mundane—decisions about force structure, research efforts, or communicated strategy have confounded planners, sometimes causing the opposite of the intended effect.

Nov 27, 2019

Repatriating refugees to dangerous countries violates international law and breeds conflict, instability, and future crises. Regional work visas and long-term integration into host countries are more promising solutions.

Speaking at the Idea Exchange, organisers are optimistic of bringing Rushdie to the JLF.

Jan 28, 2020

In the unintuitive world of nuclear weapons strategy, it’s often difficult to identify which decisions can serve to decrease the risk of a devastating nuclear conflict and which might instead increase it. Such complexity stems from the very foundation of the field: Nuclear weapons are widely seen as bombs built never to be used. Historically, granular—even seemingly mundane—decisions about force structure, research efforts, or communicated strategy have confounded planners, sometimes causing the opposite of the intended effect.

Nov 27, 2019

Repatriating refugees to dangerous countries violates international law and breeds conflict, instability, and future crises. Regional work visas and long-term integration into host countries are more promising solutions.

Nov 27, 2019

Repatriating refugees to dangerous countries violates international law and breeds conflict, instability, and future crises. Regional work visas and long-term integration into host countries are more promising solutions.

Nov 27, 2019

Repatriating refugees to dangerous countries violates international law and breeds conflict, instability, and future crises. Regional work visas and long-term integration into host countries are more promising solutions.

Jan 28, 2020

In the unintuitive world of nuclear weapons strategy, it’s often difficult to identify which decisions can serve to decrease the risk of a devastating nuclear conflict and which might instead increase it. Such complexity stems from the very foundation of the field: Nuclear weapons are widely seen as bombs built never to be used. Historically, granular—even seemingly mundane—decisions about force structure, research efforts, or communicated strategy have confounded planners, sometimes causing the opposite of the intended effect.

Jan 28, 2020

In the unintuitive world of nuclear weapons strategy, it’s often difficult to identify which decisions can serve to decrease the risk of a devastating nuclear conflict and which might instead increase it. Such complexity stems from the very foundation of the field: Nuclear weapons are widely seen as bombs built never to be used. Historically, granular—even seemingly mundane—decisions about force structure, research efforts, or communicated strategy have confounded planners, sometimes causing the opposite of the intended effect.

Jan 28, 2020

In the unintuitive world of nuclear weapons strategy, it’s often difficult to identify which decisions can serve to decrease the risk of a devastating nuclear conflict and which might instead increase it. Such complexity stems from the very foundation of the field: Nuclear weapons are widely seen as bombs built never to be used. Historically, granular—even seemingly mundane—decisions about force structure, research efforts, or communicated strategy have confounded planners, sometimes causing the opposite of the intended effect.

Jan 28, 2020

In the unintuitive world of nuclear weapons strategy, it’s often difficult to identify which decisions can serve to decrease the risk of a devastating nuclear conflict and which might instead increase it. Such complexity stems from the very foundation of the field: Nuclear weapons are widely seen as bombs built never to be used. Historically, granular—even seemingly mundane—decisions about force structure, research efforts, or communicated strategy have confounded planners, sometimes causing the opposite of the intended effect.

Nov 27, 2019

Repatriating refugees to dangerous countries violates international law and breeds conflict, instability, and future crises. Regional work visas and long-term integration into host countries are more promising solutions.

Jan 28, 2020

In the unintuitive world of nuclear weapons strategy, it’s often difficult to identify which decisions can serve to decrease the risk of a devastating nuclear conflict and which might instead increase it. Such complexity stems from the very foundation of the field: Nuclear weapons are widely seen as bombs built never to be used. Historically, granular—even seemingly mundane—decisions about force structure, research efforts, or communicated strategy have confounded planners, sometimes causing the opposite of the intended effect.