Perspectives on Life Sciences
247 total results. Page 1 of 10.
FDA recently issued a guidance document that intends to reshape the agency’s cornerstone medical device program – the 510(k) pathway. Traditionally, devices commercialized through the 510(k) pathway would need to demonstrate substantial equivalence to a similar legally marketed device, i.e., a “pred
Senior Director of Regulatory Policy Brian Ronholm was quoted in Food Chemical News’ article discussing USDA non-Senate confirmed positions at USDA. The article noted experts Mindy Brashears, Naomi Earp, and Scott Hutchins, nominated by President Donald Trump for the Senate-confirmed positions at US
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
In this video episode of Fashion Counsel, Fashion & Retail Leader Anthony Lupo and Life Sciences Leader James Ravitz discuss the fine line between wearable tech and a medical device.
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 jurisdictional skirmish over the regulation of cell-cultured meat products appears to have been resolved with the recent announcement by the FDA and the US Department of Agriculture of a joint regulatory framework in which the two agencies would share jurisdictional responsibilities.
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.