Perspectives on Life Sciences
199 total results. Page 1 of 8.
On June 6, the US Department of Agriculture (USDA or Agency) released its proposed revision to Part 340, the regulations implementing USDA’s authority over genetically engineered (GE) organisms, including GE plants.
The Action Plan is intended to clarify the agency’s science- and-risk-based approach to regulating such products with the stated goals of fostering innovation, enhancing public communication and outreach, and increasing coordination between FDA and its federal and international counterparts.
Last week, USDA’s Agricultural Marketing Service convened a webinar to accept public comments on implementing the hemp provisions included in the 2018 farm bill.
The Food and Drug Administration (FDA) and USDA’s Food Safety and Inspection Service (FSIS) last week announced a formal regulatory framework on the oversight of cell-cultured meat products.
FDA has been establishing policies to benefit new programs for the medical device industry, including opportunities in the Digital Health arena and promoting the use of Real World Evidence.
While he did not use a hemp pen like the one used by Senate Majority Leader Mitch McConnell (R-KY) to sign the conference report, President Trump signed into law the 2018 farm bill that includes a provision that legalizes hemp. Specifically, the provision would remove hemp from the federal list of c
NEW YORK – Earlier this year, Yeshiva University’s Katz Graduate Business School introduced a new 36-credit Master of Science in Biotechnology Management and Entrepreneurship designed to prepare future business leaders in the life sciences to successfully navigate the launching new medical drugs.
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 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.
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.
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.
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.”
Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.