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
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA rolls out Phase II of long-term sodium reduction plan. FDA has released new,...more
Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more
HIGHLIGHTS IN 2023 DEVELOPMENTS - FDA Takes Steps to Implement MoCRA - In 2023, the U.S. Food and Drug Administration (FDA) took several steps to implement the Modernization of Cosmetics Regulation Act (MoCRA), which...more
Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more
With the swipe of a pen, California Governor Gavin Newsom starts the California Food Safety Act countdown to a 2027 statewide ban on four popular food additives. Starting January 1, 2027, companies manufacturing, selling,...more
American Conference Institute is hosting the 7th Annual Advanced Summit on Food Law – Regulation, Compliance, and Litigation from April 18-19, 2023, in Chicago! Prepare for the future by examining current controversies,...more
On January 31, 2023, the Food and Drug Administration ("FDA") announced plans to redesign its Human Foods Program (the "Program") to better coordinate the agency's regulation of food products....more
The U.S. Food and Drug Administration (FDA) recently released an updated list of priority draft and final guidance documents related to foods and dietary supplements that the agency intends to publish by the end of this year....more
The U.S. Food and Drug Administration (FDA) recently released its Congressional Justification for the fiscal year (FY) 2023 budget. The agency is requesting $1.2 billion for its Foods Program to be allocated to initiatives...more
This month’s update kicks off spring with a Best in Show throwback ad comparing dog flea and tick medication, pivots to claims for survivalist ready-to-eat meals (don’t even try to act like you saw that coming), highlights...more
Shook Of Counsel John Johnson III will co-present “Food and Dietary Supplement Regulation Year-in-Review” on Wednesday, March 30, 2022, at the Food and Dietary Supplement Safety and Regulation Conference. The conference,...more
The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of priority draft and final guidance documents...more
For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more
The U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) recently released a list of priority draft and final guidance documents that the...more
US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other...more
What does it take to clear regulatory hurdles to bring food and drugs to market? Our Food & Beverage and FDA teams begin a series exploring best practices for you to follow and the many avenues to approval and success. First:...more
Importing dietary supplements and dietary supplement components can present many challenges. Not the least of which are those required to stay in compliance with aspects of the Food Safety and Modernization Act (FSMA)....more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Warns Company Selling CBD Oil - The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a...more
LEGISLATION, REGULATIONS & STANDARDS - U.S. Lawmakers Urge FDA to Act on CBD - A group of U.S. lawmakers, led by Reps. Chellie Pingree (D-Maine) and James Comer (R-Ky.), have urged the U.S. Food and Drug Administration...more
LEGISLATION, REGULATIONS & STANDARDS - FTC Issues Warning Letters to CBD Companies - The U.S. Federal Trade Commission has announced that it sent warning letters to three companies selling “oils, tinctures, capsules,...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
It was another active year in 2018 for class action litigation targeting the food, beverage and supplement industries. A cross-practice team from Bryan Cave Leighton Paisner has authored a roundup of the most notable...more
On February 27, 2019, Food and Drug Administration Commissioner Dr. Scott Gottlieb provided the strongest signal to date that the FDA would take action to potentially permit low-level CBD foods in the marketplace, which would...more
While the legal landscape continues to evolve in the cannabis industry, making entry into the space a potentially risky proposition, the passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”) can be a real game...more