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Activities For sNDA and Citizen’s Petition Protected by “Safe Harbor” - Classen Immunotherapies, Inc. v. Elan Pharmaceuticals,...

In a case addressing the “safe harbor” provision of 35 U.S.C. § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that information submitted to the U.S. Food and Drug...more

FCC Open Internet Advisory Procedures - Possibilities and Potential Pitfalls

As we head into this long holiday weekend, the FCC gives us something to think about. To seek guidance or not to seek guidance, that is the question. Today, the FCC released its Open Internet Advisory Opinion Procedures....more

OPM Proposes Actions To Strengthen Cybersecurity Of Its IT Systems

On June 24, 2015, the Office of Personnel Management (the “OPM”) announced several actions to strengthen its cybersecurity. The 8-page “Actions to Strengthen Cybersecurity and Protect Critical IT Systems” (the “Action Plan”)...more

FDA Announces Delay in Enforcing DSCSA Requirements for Dispensers

On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements...more

FDA Announced a Four-Month Enforcement Delay on Certain Drug Supply Chain Security Act Product Tracing Requirements for Dispensers

FDA Does Not Intend to Enforce Product Tracing Requirements Related to Dispensers’ Receipt and Maintenance of Product Tracing Information Until November 1, 2015. It Did Not Delay Dispenser Requirements With Respect to Product...more

Needed Now: Experienced and Talented Cybersecurity Professionals to Protect Government Data Systems

The announcement on June 4th of a massive cybersecurity attack that compromised data stored on Office of Personnel Management (OPM) systems for 4.2 million current and former federal employees is the most recent head-smacking...more

Marketing to Millennials [Video]

Does your legal counsel understand your customer? Your business? Your industry? At Ifrah Law, we understand all three and we strive to provide you with the expertise that will help you grow your business!...more

Advertising and Marketing News from Ifrah Law’s FTCBeat.com, Volume 6

Internet Advertising and Marketing Summer Newsletter from Ifrah Law with updates you won't want to miss!...more

U.S. Office Of Personnel Management Confirms Cyber Theft From Its Systems Is Much Broader Than Initially Reported

During a June 23, 2015 Congressional hearing, officials from the U.S. Office of Personnel Management (the “OPM”) testified that a recent breach of its data systems may have affected personal information (including social...more

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

FCC Fines AT&T $100,000,000 for Violation of Transparency Rule

In a recent enforcement action, the FCC fined AT&T $100,000,000 for violations of the Open Internet Transparency Rule (“Transparency Rule”). The Notice of Apparent Liability (“NAL”) for Forfeiture and Order stated that AT&T...more

Preparing For The Obvious At The PTAB

There is little debate that inter partes reviews have proven to be an effective means of challenging the validity of a patent. During the first two-and-a-half years, more than 73 percent of claims originally challenged in IPR...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

FDA Approves St. Jude Medical’s Upgradeable, MRI-Compatable Spinal Cord Stimulation System

St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads,...more

Newsflash, Politico: ‘Patent Death Squad’ Alive and Well

Politico, the popular political journalism publication, recently ran the story “Patent Reform Advocates: PTO Process Not Patent ‘Death Squad.’” The story was based on a blog post by patent reform advocate Unified Patents. ...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

Blog: FDA Launches New REMS Website

The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual...more

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

District Court Issues Order Allowing Plaintiffs in Case Seeking Review of Neonicotinoid Pesticides under the ESA to Utilize Extra...

On June 12, 2015, Federal District Judge Maxine Chesney issued a decision in Ellis v. Housenger (N.D. Cal.) allowing the plaintiffs to utilize expert declarations and exhibits that were not included in the certified...more

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

Court of Appeals Grants Writ of Mandamus Requiring EPA to Take Final Action on Chlorpyrifos Petition

On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by Pesticide Action Network North America and Natural Resources Defense Council in 2007. That petition...more

USPTO Pilots Expedited Patent Appeal Program But at What Price?

In a June 15, 2015 Federal Register Notice, the USPTO announced the Expedited Patent Appeal Pilot program, which will run until 2,000 ex parte patent appeals are expedited under the program, or until June 20, 2016, whichever...more

New USPTO Expedited Patent Appeal Pilot Program

On June 15, 2015, the United States Patent and Trademark Office (“USPTO”) issued Notice in the Federal Register announcing a new pilot program, the Expedited Patent Appeal Pilot. Under the program an appellant may have an ex...more

PHOs Banned in the U.S.: Landmark FDA Order Declares Partially Hydrogenated Oils No Longer Generally Regarded as Safe

On June 17, 2015, the U.S. Food and Drug Administration (FDA) issued its much-anticipated Final Determination Regarding Partially Hydrogenated Oils (Order), finding there is “no longer a consensus that partially hydrogenated...more

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