Today, the Department of Justice and Office of the Director of National Intelligence released, in redacted form, a previously classified series of Foreign Intelligence Surveillance Court filings and orders from 2009-2010 concerning the collection of bulk telephony metadata under Section 215 of the USA Patriot Act. These documents relate to a robust interaction that occurred between the Department of Justice and a telecommunications service provider that included the provider’s review of prior FISC applications, orders and opinions, regarding lawful compliance with those orders.

The Justice Department and Internal Revenue Service announced today that a federal grand jury in Anchorage, Alaska, returned a superseding indictment yesterday charging Michael D. Brandner, an Anchorage physician specializing in plastic surgery, on three counts of tax evasion.

Associate Attorney General Tony West will visit Alaska next week to discuss the Department of Justice’s efforts to protect civil rights and strengthen public safety in American Indian and Alaska Native communities.

"As a nation, we cannot, and we will not, simply stand by as the voices of Native Americans are shut out of the democratic process. I am personally committed to working with tribal authorities – and with Congress – to confront disparities and end misguided voting practices once and for all.”

The Advisory Committee of the Attorney General’s Task Force on American Indian and Alaska Native Children Exposed to Violence convenes its final public hearing in Anchorage, Alaska, today and tomorrow

"We have come to Anchorage to lessen the number of suffering children. We come to continue the important work we began six months ago when this Advisory Committee held its first hearing in Bismarck," said Associate Attorney General West

The Justice Department and the Office of the Director of National Intelligence released the following joint statement Friday

Paul D. Stockler pleaded guilty today in the U.S. District Court in Anchorage, Alaska, to three counts of willful failure to file income tax returns, the Justice Department and Internal Revenue Service (IRS) announced

The Department of Justice and the Office of the Director of National Intelligence (DNI) released the following statement Friday

Nathan Stoliar, 64, of Australia, pleaded guilty in federal court in Las Vegas today to five felonies for his role in multiple schemes, worth in excess of $41 million, to generate fraudulent biodiesel credits and to export biodiesel without providing biodiesel credits to the United States as required by law

On the second day of his federal jury trial, a Las Vegas Playboy Bloods street gang member pleaded guilty today to racketeering and drug charges, announced U.S. Attorney Daniel G. Bogden of the District of Nevada and Leslie R. Caldwell, Assistant Attorney General of the Justice Department’s Criminal Division

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.

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.

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

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 »

It’s that time of year again when we pause to reflect on the state of the industry – and there’s more to focus on in biopharma today than just the drug pricing debate. As I described last year, we host

The post Our 2019 Year In Review: Macro, Biotech, and Atlas appeared first on LifeSciVC.

From : Communities>>Regulatory Open Forum
Dear Roy, You do not mention any important functions of the syringe/applicator, other than the Primary Packaging function for which you have identified testing to assess impact. The determination of these functions (e.g. deliverable dose or dose accuracy) could provide important testing to verify that no impact on performance. Also, an assessment on the impact of the change on the usability could be required (particularly if the ergonomics/forces change) or patient risk would be prudent, which [More]

From : Communities>>Regulatory Open Forum
Dear Lee & Spyros, Many thanks for your invaluable advice - really appreciate your time in considering and providing deep insight. Kind regards, Roy Jamieson (BPharm Hons) Regulatory CMC Consultant

Takeda in global licensing agreement with ProThera to develop plasma-based therapies for inflammatory conditions.

While dietary supplement sales have surged in recent months, the extent of the economic damage caused by the novel coronavirus and COVID-19 could lead to some very tough quarters as families and businesses start to run out of money.

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 […]

For the high school and college classes of 2020 — and their families — the coronavirus outbreak has left a large, empty space where signature coming-of-age moments should be.

Download the latest CBSE syllabus of all subjects of Class 9. Analyse the syllabus before studyng new chapters in new academic session.

CBSE Result 2020: Amid COVID - 19 pandemic & lockdown, Kendriya Vidyalaya Sangathan (KVS) and many state boards (like Gujarat, Haryana, Puducherry) have decided to promote school students (Classes 1st to 9th & Class 11th). After this, many students & parents are seeking clarity from the Central Board of Secondary Education (CBSE). Check updates.

The funding will be used to spruce up technology and expand product offerings.

The post India Deal Monitor: RTP Global leads $9m funding in Classplus and more updates appeared first on DealStreetAsia.

In vitro and mouse studies suggest THZ1, a covalent CDK7 inhibitor, could help treat neuroblastoma and other cancers driven by MYCN and other c-MYC (MYC)-family oncoproteins.