Perspectives on Life Sciences
215 total results. Page 1 of 9.
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.
US House of Representatives Approves Legislation to Repeal the Affordable Care Act’s Medical Device Tax, Bill Awaits Senate Action
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.
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
Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies.
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.
FDA partner Georgia Ravitz and counsel Naomi Halpern discussed the withdrawal of Import Alert 66-38 in an article for Happi Magazine titled, “Anti-Aging Products Are Not Drugs! Does the withdrawal of Import Alert 66-38 signal a change of heart at the US Food and Drug Administration?”
On January 16, 2018, FDA Commissioner Scott Gottlieb, M.D., delivered a presentation, “Fostering Transparency to Improve Public Health” to the John Hopkins Bloomberg School of Public Health.
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.
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.
This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.
Senior director of regulatory policy Brian Ronholm recently analyzed the current debate over line speeds at poultry slaughter establishments in an opinion piece for Food Safety News titled, “Eschewing Obfuscation on Poultry Slaughter Line Speed.”
FDA counsel Brian Malkin discussed the recent language change in the internal FDA policy manual in an article published by Pink Sheet titled, “In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word?”