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
LEGISLATION, REGULATIONS & STANDARDS - GAO: FDA Should Finalize Plans to Implement New Traceability Rule - The Government Accountability Organization (GAO) has recommended that the U.S. Food and Drug Administration...more
On April 14, 2023, the U.S. Food and Drug Administration filed a petition submitted by the Environmental Defense Fund (EDF) and several other NGOs requesting that the agency repeal its regulation authorizing the use of...more
The U.S. Food and Drug Administration (FDA) has written a letter to the manufacturers and developers of new plant varieties, urging them to fully consider the potential ramifications of transferring the genes of allergens to...more
FDA Proposes Changes to Standards of Identity for Foods Including Salt- The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would change the standards of identity (SOIs) for foods that include salt to...more
The U.S. Food and Drug Administration (FDA) has issued guidance indicating that it will not enforce particular provisions implementing the Food Safety Modernization Act (FSMA). “In certain situations the FDA has determined it...more
Several advocacy groups, including the Environmental Defense Fund, Consumer Reports and Environmental Working Group, have filed a petition with the U.S. Food and Drug Administration (FDA) “requesting that the agency remove...more
USDA, FDA Issue Joint Statement on Transmissibility of COVID-19 on Food Packaging - The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have issued a joint statement stating that “there is no...more
Court Dismisses Beef “Product of the USA” Lawsuit - A New Mexico federal court has dismissed allegations that several food companies falsely labeled beef as a “Product of the USA” because the cattle were raised in other...more
Schumer Urges USDA To Delay Hemp Rule - U.S. Sen. Chuck Schumer (D-N.Y.) has called on the U.S. Department of Agriculture (USDA) to “delay the issuance of a U.S. Domestic Hemp Production Program final rule until 2022 and...more
Food Safety On March 9, the European Food Safety Authority announced that there is no evidence that food is a source or transmission route for coronavirus. FDA has taken the same position, both in a stakeholder briefing held...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...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 - Bipartisan Bill Introduced to Standardize Food Date Labels - U.S. Reps. Chellie Pingree (D-Maine) and Dan Newhouse (R-Wash.) have introduced the Food Date Labeling Act, which aims...more
LEGISLATION, REGULATIONS & STANDARDS - Proposed Amendment Would Provide Funds for FDA Oversight of CBD - Rep. Jerry McNerney (D-Calif.), in partnership with the Natural Products Association, has reportedly filed an...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
LEGISLATION, REGULATIONS & STANDARDS - USDA Redistributes Responsibilities Among Agencies - The U.S. Department of Agriculture (USDA) has reallocated responsibilities between its agencies, resulting in the elimination...more
LEGISLATION, REGULATIONS & STANDARDS - Personal Care Products Legislation Introduced in Congress - Rep. Janice Schakowsky (D-Ill.) has introduced the Safe Cosmetics and Personal Care Products Act of 2018, which would...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Provides Update on Added Sugar Labeling for Honey and Maple Syrup - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement providing an update...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Modernization for Dairy Product Identities - Following his related statements at a conference, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has...more
Organic Group Objects to Withdrawal of OLPP - A group of organic food producers, retailers and certifiers has published a full-page advertisement in The Washington Post containing the text of a letter to Secretary of...more
Top News - FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions - On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
FDA Announces Intent Not to Enforce Portions of FSMA - The U.S. Food and Drug Administration (FDA) has announced it will not enforce certain provisions of the Food Safety Modernization Act (FSMA) because the agency needs...more
USDA Inspector General Recommends Reform of AMS Organic Program for Imports - The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more
Furans in Baby Food May Pose Health Risk, EFSA Reports - The European Food Safety Authority (EFSA) has issued an assessment of the risks of furans and related compounds 2- and 3-methylfurans, concluding that they pose a...more
TOP NEWS - FDA Proposes New Compliance Dates for the Water Provisions of the Produce Safety Final Rule - On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce...more