Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
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
On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more
On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more
On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional approval of CASGEVY (exagamglogene autotemcel...more
On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA. SCD is a group of inherited...more
In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more
Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more
On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc.’s genome-edited, heat-tolerant cattle, pose a “low risk to humans, animals, the food...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