Perspectives on Life Sciences

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. 

A review of FSIS recall data from the past five years indicates that recalls of meat and poultry products due to the presence of foreign matter contamination have grown in number, particularly over the past year.

From large corporations to small nonprofits, from urban centers to rural communities, the 2016 elections will have an impact across all sectors of the economy and globally as well.

Earlier this week, the US Food and Drug Administration (FDA) issued revised food safety standards known as the “Manufactured Food Regulatory Program Standards” (MFRPS).

On August 31, 2016, California took a long-awaited step in publishing new major changes to the Proposition 65 warning regulations; the first of such amendments in more than a decade.

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.

FDA continues to maintain an aggressive enforcement stance against cosmetics/personal care product companies and has already issued a record 19 Warning Letters to such companies so far in 2016.

The US Food and Drug Administration published a Final Rule in the Federal Register on September 6, 2016, which establishes that Over-the-Counter consumer antiseptic wash products containing one of 19 specific active ingredients (listed below) can no longer be marketed.

As Congress returns from its summer recess and begins wrapping up its work for the remainder of 2016, one of the many outstanding issues is FDA regulation of cosmetics and personal care products.

Forty-two Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2017.

Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of the Controlled Substances Act for the fifth straight time.

The Beer Institute (BI) announced last week that is was implementing a “Brewer’s Voluntary Disclosure Initiative” intended to encourage its membership to begin disclosing nutritional information about its products on product labeling, packaging and on product websites.

The House of Representatives has voted 306-117 to approve the bipartisan GMO disclosure bill to amend the Agricultural Marketing Act of 1946 and to establish a mandatory National Bioengineered Food Disclosure Standard.

Late Thursday night, the Senate voted 63-30 to approve a bipartisan GMO disclosure bill hammered out earlier by Agriculture Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI). 

Last week, bipartisan legislation was introduced in the US Senate and the House of Representatives to amend the Controlled Substances Act and ease federal obstacles for medical researchers to conduct clinical studies on the medical benefits of marijuana.

Earlier this week, the US House approved a bill by an overwhelming majority that will significantly reform the 40-year-old Toxic Substances Control Act.

Retailers should implement routine checks on advertising and pricing to ensure language is accurate and consistent with offerings.

FDA announced Tuesday that it will begin reevaluating how it regulates the use of the term “healthy” on food labeling.

FDA recently issued its final guidance on restaurant menu labeling intended to help restaurants and similar retail food establishments understand nutrition labeling requirements under the Federal Food, Drug, and Cosmetic Act that may apply to them.

In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

Arent Fox filed an amici brief on behalf of the Wisconsin Alumni Research Foundation, the Indiana University Research and Technology Corporation, and San Diego Intellectual Property Law Association. Our brief focused on the following three errors in the Federal Circuit’s rationale.

The US Drug Enforcement Administration recently announced that it is evaluating whether to downgrade the classification of marijuana under the Controlled Substances Act, which could allow more research into its potential medicinal benefits. A decision is expected this summer.  

The Federal Trade Commission announced on April 12 that it reached settlement agreements with four companies that market skin care products, shampoos, and sunscreens online over charges that they falsely claimed that their products are “ALL NATURAL” or “100% NATURAL,” despite the fact that they cont

As in previous years, 2015 brought a combination of expected and unexpected holdings by the Supreme Court and the Federal Circuit.

Last week, the Department of Health and Human Services (HHS) and Department of Agriculture (USDA) released the federal government’s 2015-2020 Dietary Guidelines.