Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more
The practice of altering plant genetics to better suit human needs, dates back thousands of years. What was once done through selective plant breeding – as well as alterations beyond what is possible with selective breeding –...more
On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more
Ever since Watson and Crick ended their seminal Nature paper in 1953 by saying that: "It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the...more
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more
Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Emily Chee, the US General Manager of Novartis Gene Therapies, a biotech company specializing in gene therapies for rare...more
Editor’s Note: In a new white paper, summarized below, Manatt Health discusses emerging reimbursement models for cell and gene therapies. The paper provides an overview of current Medicaid, Medicare and commercial coverage,...more
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020...more
While it may feel like FDA’s attention has been focused on COVID-19 for nearly two years, as we have written about in a previous blog post, FDA is looking to the future, and particularly, one that signals exciting prospects...more
Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer...more
The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine....more
FDA announced the introduction of a collaboration between the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) to provide the agency’s view of the current science in...more
A new report out Tuesday from the Food & Drug Administration reveals that drug maker Novartis “concealed manipulated data” from the agency “while applying for approval of an extremely expensive gene therapy treatment and then...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when mothers carry genes for mitochondrial diseases. Similar to in vitro...more
On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more
On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more
FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more
Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing...more
On October 15, 2015, the Food and Drug Administration (FDA) posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated...more
The White House, through the Office of Science and Technology Policy (OSTP), announced a major initiative to overhaul the regulation of biotechnology products (OSTP Memo), which are products developed through genetic...more
Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more