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
Last week, FDA submitted a report to Congress detailing the Agency’s progress on developing an enforcement discretion policy (i.e., a policy of not taking enforcement action) on hemp-derived cannabidiol (CBD). At the same...more
On February 26, 2020 the Food and Drug Administration’s (“FDA”) new commissioner, Dr. Stephen Hahn, acknowledged the growing consumer demand for CBD products. “People are using these [CBD] products,” Hahn said in his first...more
The Food and Drug Administration (FDA), following up on its public concerns about the science, safety, effectiveness and quality of unapproved products containing cannabidiol (CBD), recently issued a warning letter to...more
Products containing cannabidiol (“CBD”), a compound derived from cannabis plants, are part of a growing market segment that is on a fast-track to becoming global within the next five years. CBD-containing products, from gummy...more
While it was ostensibly convened to gather scientific input from stakeholders on how to appropriately regulate cannabis-infused products, the Food and Drug Administration (FDA) also used the May 31, 2019 public hearing as a...more
• With the dramatic expansion of CBD products in the market, the U.S. Food and Drug Administration (FDA) is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed. • The...more
On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health...more
The Transportation Security Administration (TSA) recently changed its policy on hemp-derived products. Products and medications that contain lawfully produced hemp-derived cannabidiol (CBD) are now permitted on flights....more
The Food and Drug Administration (“FDA”) held its first-ever public hearing on cannabidiol (“CBD”) on Friday, May 31, 2019 with over one hundred (100) speakers and ten (10) hours of testimony. The purpose of the hearing was...more
On Friday, May 31, 2019, the Food and Drug Administration (“FDA”) conducted its first public hearing to create a regulatory framework for the legal marketing and sale of cannabidiol (“CBD”) products. The FDA asked the...more
On May 31, 2019, the Food & Drug Administration (“FDA”) held its first public hearing on regulating the processing, dispensing, and ingesting of Cannabidiol (“CBD”). The FDA’s Deputy Commissioner, Dr. Amy Abernethy, noted...more
As the market for Cannabidiol (CBD) products continues to rapidly expand across the country, federal agencies are in the early phase of establishing regulations for the processing, dispensing, and ingestion of CBD products....more
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety,...more
On May 31, 2019, the Food and Drug Administration (FDA) held its first public hearing concerning products containing cannabis or cannabis-derived compounds (in particular, cannabidiol (CBD), a popular additive to food,...more
In late 2018, President Trump formally signed the Agricultural Improvement Act of 2018 (2018 Farm Bill) into law, and in turn declassified hemp as a Schedule 1 substance under the Controlled Substances Act (CSA). Hemp is...more
The Agency plays a significant role in the evolving legal landscape governing certain cannabis-derived products. Key Points: ..New law lifts or eases some, but not all, federal obstacles for certain cannabis-derived...more
Historically, all forms of cannabis—both hemp and marijuana—have been federally designated as illegal substances. That all changed this past December when the President signed the Agricultural Improvement Act (2018 Farm Bill)...more
Introduction: FDA to Hold Public Hearing - The U.S. Food and Drug Administration (FDA) recently announced it will hold a public hearing on May 31, 2019. This important hearing presents an opportunity for consumers,...more
On April 2, 2019, the Federal Food and Drug Administration (FDA) issued a statement and announced a public hearing on consumer products derived from cannabis and its components, including cannabidiol (CBD). ...more
FDA Announces Next Steps in Cannabis Regulation - The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for...more
On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional...more
On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more
LEGISLATION, REGULATIONS & STANDARDS - FDA to Hold CBD Public Hearings - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly said in a February 27, 2019, hearing before the House...more
As reported here, the Oncologic Drug Advisory Committee (ODAC) held a public hearing today at the U.S. Food & Drug Administration to discuss and vote on Celltrion’s Biologics License Application for CT-P10, a proposed...more
The U.S. Food and Drug Administration (FDA) has announced it will hold a public meeting on November 27 in Washington, D.C. to give stakeholders – including health care providers, patients, manufacturers, wholesalers,...more