Perspectives on Life Sciences
230 total results. Page 1 of 10.
The FDA has delayed the date on which it plans to enforce compliance with certain Unique Device Identification (UDI) requirements, prompting a concerted sigh of relief throughout the medical device community.
Byron Dorgan, Philip S. English*, Dan H. Renberg, Jon S. Bouker, Craig Engle, Norman F. Lent III, Sonja L. Nesbit*, Laura E. Doyle, Angela Ebiner*, Katherine Flocken*, Mariana Acuna*, Daniel Sjostedt*
Below is a roundup of headlines that matter and key takeaways from the industries and issues we're following closely. We'll be back later today with more in-depth analysis.
Byron Dorgan, Philip S. English*, Dan H. Renberg, Jon S. Bouker, Craig Engle, Norman F. Lent III, Sonja L. Nesbit*, Laura E. Doyle, Angela Ebiner*, Katherine Flocken*, Mariana Acuna*, Daniel Sjostedt*
As the dust settles on a campaign cycle that was unprecedented in many ways, we have composed this biennial post-election analysis to assist our clients in assessing the potential impact of the elections on their organizations and their industries.
WASHINGTON — Twenty-four Arent Fox LLP practices have been recognized in the 2019 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.
The Food and Drug Administration is maintaining its August 2017 commitment to step up enforcement against violative stem cell therapy and regenerative medicine companies. But FDA’s activity hasn’t stopped the Federal Trade Commission from flexing its own regulatory muscle against the same industry.
The Department of Health and Human Services (HHS) has issued a proposed rule (PR) which would require any television advertisement for a drug or biological covered by Medicare or Medicaid to include a disclosure of the product’s “current list price” for a “typical” thirty day supply.
Efforts to update FDA’s personal care products regulations continue as Rep. Jan Schakowsky (D-IL) recently introduced H.R. 6903, the “Safe Cosmetics and Personal Care Products Act of 2018.”
Cardiologists are being challenged to find ways to incorporate data from a new OTC mobile medical app into their practices and patient interactions. As wearable technology becomes increasingly medical, this dynamic may represent a harbinger of future health management obstacles.
Food Safety News published an article written by Senior Director of Regulatory Policy Brian Ronholm discussing cell-cultured meat.
Through a series of recent statements, FDA Commissioner Scott Gottlieb has signaled that the agency is prepared to assert its enforcement authority in reviewing label claims and modernizing standards of identity for certain products.
Forty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2019.
Earlier this week the Court of Justice of the European Union, the EU’s highest court, issued a decision clarifying whether the EU would regulate products of innovative breeding techniques, like gene editing, under the EU’s Directive 2001/18, the principal EU law governing the regulation of GMOs.
On July 24, 2018, the House of Representatives approved 283-132 a bill (H.R. 184, the Protect Medical Innovation Act of 2017) to repeal the excise tax on the sale of a medical device by the manufacturer, producer, or importer.
The United States Department of Agriculture and the Food and Drug Administration have recently initiated processes to evaluate and propose revisions to their approaches to the regulation of products of agricultural biotechnology.
On May 31, 2018, the FDA announced two new guidances designed to help generic drug manufacturers to obtain access to shared Risk Evaluation and Mitigation Systems programs, thereby promoting competition and access.
Brian Ronholm*, Karen Ellis Carr, James R. Ravitz, Georgia C. Ravitz, Stanley H. Abramson, Emily M. Leongini
Late last week, the Food and Drug Administration declared its jurisdiction over animal cell culture technology through a public meeting announcement and a statement by Commissioner Scott Gottlieb.
Medical devices containing animal derived ingredients that have been approved by the Food and Drug Administration now may enter the US without the need for an import permit from USDA’s Animal and Plant Health Inspection Service.
A New Jersey-based company, Aromaflage, and its owners have agreed to settle charges brought by the Federal Trade Commission (FTC) regarding the company’s sale of sprays and candles that claim to be insect-repelling.
Arent Fox is pleased to announce the launch of a new Blockchain group that pulls together attorneys from a number of the firm’s top practices to help clients navigate this emerging technology.
A recent FDA guidance document describes a new program under which the agency plans to leverage objective performance criteria to reduce burden on manufacturers of class II medical devices.
Yesterday, USDA formally announced that it “does not regulate or have any plans to regulate plants” created using new breeding techniques, such as gene editing, as long as such plants “are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.”
On March 6, 2018, the US Food and Drug Administration issued an authorization letter to 23andMe, Inc. that permits marketing of the company’s genetic test for use in screening consumers for select BRCA1/BRCA2 breast cancer gene mutations.
Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.
Late last month, an advisor to the Court of Justice of the European Union issued an opinion recommending that plants produced using innovative breeding techniques, like gene editing, be regulated like conventionally-bred plants rather than under the EU’s genetically modified organism Directive, the
Arent Fox Health Care partner and co-practice group leader Stephanie Trunk was nominated by corporate counsel to the 2018 Client Choice™ award list for the District of Columbia. Client Choice™ recognizes law firms and partners that stand apart for the excellent client service they provide.