Science, Computers & Technology › Administrative Law

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

Legislative Update Report - Apr 12, 2013

Federal Government Regulations: Canada Gazette, Part II, March 27, 2013: Contraventions Act - SOR/2013-41 Regulations Amending the Application of Provincial Laws Regulations. Farm Products...more

Compounding Animal Drugs from Bulk Ingredients

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more

MoFo New York Tax Insights - Volume 4, Issue 4 - April 2013

In This Issue: New York Court of Appeals Upholds “Amazon” Statute; Guilty Plea and $5.5 Million Settlement Resolve New York’s False Claims Case; City ALJ Dismisses Case Seeking Interest on $30 Million Refund;...more

Emails and Text Messages On Personal Devices Subject to Public Records Act - Judge’s Ruling Demonstrates Risk to Public Agencies;...

A Santa Clara County Superior Court judge recently ruled that emails and text messages concerning city business but stored on a public official’s personal device are subject to the Public Records Act (PRA). The PRA request at...more

FDA Emphasizes Patient-Specific Prescriptions

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses

To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more

Levick Weekly - March 1, 2013: The Libor Scandal; Prosecutors Have A New Plan

In This Issue: - The Food Safety Modernization Act - The LIBOR Scandal - Prosecutors Have a New Plan - Food Safety Compliance - A Hogan Lovells Roundtable - Lessons from the Oldest CEO Succession Plan on...more

Capper, Dir of National Intelligence, et al v. Amnesty International USA et al

SCOTUS Dismisses Federal Wiretapping Challenge

Full text copy of Supreme Court's dismissal of lawsuit challenging federal wiretapping program. On Tuesday, February 26, 2013, a divided Court dismissed a challenge to the FISA Amendments Act, which permits federal...more

Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation

The Obama Administration issued a Report earlier this month, entitled "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets," that sets forth its efforts to prevent trade secret misappropriation. The Report...more

FDA Tightens Requirement for Patient-Specific Prescriptions in the Wake of the Meningitis Outbreak

In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription. In...more

SBA Rules: Investment Funds Can Now Be Majority Owners of SBIR Companies

The Small Business Administration (SBA) recently amended the rules relating to its Small Business Innovation Research (SBIR) program and Small Business Technology Transfer (STTR) program. The new SBA rules implement the...more

EU Proposed Directive on Network and Information Security

On 7 February, the European Commission (EC) published an EU Cyber Security Strategy encompassing a proposed Directive on Network and Information Security (NIS Directive). The aim of the Strategy and NIS Directive is to...more

2012 Year in Review: FDA OPDP Warning Letters and Untitled Letters

In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

HIPAA Omnibus Final Rule - What's in it for Patients?

The Final Rule offers significant changes to patient rights and patient protections. (There is much more to the rule, but other aspects are not addressed in this post. Here you may find a link to the HIPAA Omnibus Rule, a...more

USPTO Soliciting Comments on Software Patent Issues

The United States Patent and Trademark Office announced its intent earlier this month to form a “Software Partnership” with the software community in order to enhance the quality of software-related patents (the “Notice”)...more

Finally! HHS Office of Civil Rights Releases HIPAA Omnibus Rule With Sweeping Changes to Compliance Requirements and Enforcement

The final regulations from Department of Health and Human Services Office of Civil Rights (OCR) containing modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (Omnibus Rule) have finally...more

Health Law Blog: Final HIPAA Rules Released

Yesterday, the U.S. Department of Health and Human Services (HHS) released the long-awaited final rules implementing changes to the HIPAA privacy and security rules enacted in 2009 by the HITECH Act....more

The HIPAA/HITECH Final Rule Has Been Released

The long awaited HIPAA/HITECH Final Rule is out. The final rule is effective March 26, 2013, but covered entities (CEs) and business associates (BAs) will have 180 days beyond the effective date to come into compliance....more

Brace for Impact – Final HITECH Rules Will Require Substantially More Breach Reporting

HHS has finally issued its omnibus HITECH Rules. Our firm will issue a comprehensive summary of the rules shortly, but of immediate import is the change to the breach reporting harm threshold. The modification will make it...more

Hospitals Need To Focus On Data Privacy And Security

To restate the obvious, hospitals operate in a risky environment. They face a variety of risks and a blanket of government regulations. You have to admire the Chief Compliance Officer at a hospital. They learn to live with...more

Hospitals Need To Focus On Data Privacy And Security

To restate the obvious, hospitals operate in a risky environment. They face a variety of risks and a blanket of government regulations. You have to admire the Chief Compliance Officer at a hospital. They learn to live with...more