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  2. Life Sciences

Insights on Life Sciences

360 total results. Page 10 of 15.

Investigations Blog
Is DOJ Changing Its Approach to Enforcement? What Regulated Entities Need to Know 
February 2, 2018
D. Jacques Smith, Michael F. Dearington, Randall A. Brater

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies.

Events
Q1’s Annual Food Labeling Conference
January 29, 2018
Karen Ellis Carr, Emily Cowley Leongini

Karen Carr and Emily Leongini to Present at Q1’s Annual Food Labeling Conference. Arent Fox partner Karen Carr and associate Emily Leongini are scheduled to speak at the Q1 Productions’ 5th Annual Food Labeling Conference.

Events
New York State Bar Association Food, Drug & Cosmetic Law Section Annual Meeting and Reception
January 25, 2018
Karen Ellis Carr

Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.

Investigations Blog
Another One Bites the Dust: Court Tosses Nearly $350 Million False Claims Act Verdict Under Escobar
January 24, 2018
D. Jacques Smith, Randall A. Brater, Michael F. Dearington

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court.

Health Care Counsel Blog
Medical Device Manufacturers Afforded Temporary Tax Relief
January 23, 2018
Dan H. Renberg

As was widely reported, Congress approved legislation late Monday, January 22, 2018 to provide continuing appropriations for federal agencies through February 8, 2018, ending the government shutdown that began Saturday.

Alerts
Biotech Policy Takes Shape: Rural Task Force Encourages Innovation and Regulatory Coordination
January 22, 2018
Alexander H. Spiegler, Karen Ellis Carr, Stanley H. Abramson
Alerts
Chemical & Life Sciences Patent: Year In Review 2017
January 19, 2018
Alexander H. Spiegler

This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.

Alerts
FDA Taps the Brakes on Certain Aspects of FSMA Compliance
January 17, 2018
Brian P. Waldman

Recently, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety Modernization Act. 

News
Stephanie Trunk Quoted on PhRMA Drug Pricing Lawsuit in Bloomberg BNA
December 18, 2017
Stephanie Trunk

The Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit against the state of California in response to the state’s new drug price law. 

Alerts
Companies Marketing CBD Products Be Warned: FDA Is Watching
November 20, 2017
Emily Cowley Leongini

The US Food and Drug Administration recently issued warning letters to four companies.

Alerts
FTC Holds Public Workshop to Consider If Hatch-Waxman Is Working for Prescription Drug Competition
November 13, 2017
Stephanie Trunk

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”

Press Release
U.S. News and Best Lawyers Rates 22 Arent Fox Practices Among Best in the Country
November 2, 2017

Twenty-two Arent Fox LLP practices have been recognized in the 2018 “Best Law Firms” rankings that are published annually by U.S. News & World Report and Best Lawyers.

News
Karen Carr Pens Food Labeling Article for Food Safety Tech
October 17, 2017
Karen Ellis Carr

When the National Bioengineered Food Disclosure Standard was signed into law last year, it represented the culmination of an extended period of regulatory and legislative activity on food labeling issues.

Alerts
More Controls Needed to Prevent Organic Import Fraud, Says USDA OIG
October 12, 2017
Karen Ellis Carr

The US Department of Agriculture needs to strengthen its controls over the approval and oversight of agreements for the import of organic products into the US, according to a recent audit report issued by the Office of the Inspector General at USDA.

Alerts
Another Front Opens Up on Food Disclosure
October 10, 2017
Karen Ellis Carr, Stanley H. Abramson

The food industry potentially faces a new challenge on disclosure at the local level with the recent passage of a San Francisco ordinance addressing antibiotic use.

Alerts
FDA Requires Pharma Companies to Certify Drug Listing Info
October 6, 2017
Stephanie Trunk, Emily Cowley Leongini

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.

Alerts
USDA Releases Bioengineered Food Disclosure Report
September 14, 2017
Karen Ellis Carr, Stanley H. Abramson

While acknowledging some notable challenges, a recent USDA study concluded that most consumers seeking information on their food purchases would be able to access this information, given the proper education and tools to do so.

Alerts
FDA Announces “New” Framework to Regulate Stem Cell Therapies and Regenerative Medicine
September 8, 2017
Emily Cowley Leongini

Last week, FDA Commissioner Gottlieb issued a statement describing the Agency’s “new” policy for regulating stem cell therapies and regenerative medicine. 

Press Release
The Best Lawyers in America 2018 Recognizes 42 Arent Fox Attorneys
August 16, 2017

Forty-two Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2018.

Alerts
Court Upholds FDA’s Authority to Regulate E-Cigarettes
August 1, 2017
Emily Cowley Leongini

On July 21, the US District Court for the District of Columbia upheld FDA’s authority to regulate e-cigarettes and other electronic nicotine delivery systems (“ENDS”) as though they are tobacco, even though these products do not actually contain tobacco. 

Alerts
Pew Report Confronts the Biggest Challenge that Faces Meat and Poultry Safety
July 24, 2017
Karen Ellis Carr

One of the primary reasons the United States lacks a national animal identification system is the fervent perception among farmers and ranchers that such a system would result in government control over their livestock and an invasion of privacy.

Alerts
FDA Holds Public Meeting on Innovation in Drug Development and Accelerating Access to Generic Medicines
July 20, 2017
Janine A. Carlan, Bradford C. Frese

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act.

Health Care Counsel Blog
FDA Issues Draft Guidance For Product Identifier Requirements
July 7, 2017
Stephanie Trunk, Emily Cowley Leongini

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, with a 60-day comment period ending around September 3, 2017.

Alerts
Consumer Groups File False Advertising Suit Over ‘100% Natural’ Claim, Alleging Residues in Poultry
July 5, 2017
Karen Ellis Carr, Emily Cowley Leongini

Continuing a trend that is certain to keep growing, three consumer groups recently filed a lawsuit against Sanderson Farms alleging false advertising for their poultry products labeled “100 percent natural.”

Alerts
FDA Publishes Action Plan Designed to Address Generic Drug Competition Barriers
June 28, 2017
Brian P. Waldman

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency’s rules have been, in the agency’s view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.

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