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
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
Food and beverage companies may be surprised to learn that the U.S. Food and Drug Administration (“FDA”) is not the exclusive regulatory authority over the safety of foods and beverages. Indeed, other governmental authorities...more
With the completion of the voluntary phaseout of one form of short-chain per- and polyfluoroalkyl substances (PFAS) as a grease-proofing agent, the U.S. Food and Drug Administration (FDA) has rejected the view that...more
The U.S. Food and Drug Administration (FDA) recently announced the results of its pilot program evaluating whether several third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls...more
Am I making a “cosmetic product”? If you are a manufacturer, packer, importer, or distributor, the first question you should be asking is whether your product falls under the definition of a “cosmetic product,” which...more
A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. Such a government initiative would significantly deter...more
The US Food and Drug Administration (FDA) has changed its policy of allowing import entries to declare the identity of the Foreign Supplier Verification Program (FSVP) importer as “unknown.” Effective July 24, 2022, food...more
Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary...more
The U.S. Food and Drug Administration (FDA) recently opened an application portal for a Voluntary Qualified Importer Program (VQIP) for fiscal year 2022. Through a voluntary, fee-based model, VQIP provides participating...more
On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium...more
Al Stewart’s 1970s song, “On the Border,” comes to mind every so often when an existing or new client contacts us as their product is stopped at the United States border by the Food and Drug Administration. Lately, during...more
In response to the COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) has announced it will begin requesting that importers send the agency records required under the Foreign Supplier Verification Programs (FSVP)...more
On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued guidance to food manufacturers and importers in response to the COVID-19 pandemic. In the guidance, FDA stated it will temporarily not enforce supplier...more
On March 17, 2020, in light of the ongoing global public health emergency and associated travel restrictions, the FDA announced a temporary policy adjustment for food facilities with certain supplier verification obligations...more
The Food and Drug Administration’s (FDA) “express lane” for food importers, the Voluntary Qualified Importer Program (VQIP), is now accepting applications for the period between October 1, 2020 and September 30, 2021,...more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP). The document contains a...more
The Food Safety Modernization Act (“FSMA”) ushered in a sea change in the government’s regulation of food safety. Pursuant to FSMA, the FDA has promulgated a series of rules, including a 2015 rule related to the Foreign...more
On July 30, 2019, the U.S. Food and Drug Administration (FDA) issued its first Warning Letter to an importer for violations of the Foreign Supplier Verification Program (FSVP) requirements at 21 C.F.R. Part 1, Subpart L (21...more
The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in connection with the Foreign Supplier Verification Programs (FSVP) regulation....more
The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, has been hailed as a historic first overhaul of our nation’s food safety system in more than 70 years. The sweeping changes follow decades of food...more
August has been an active month for the Food and Drug Administration (FDA), as the agency released guidance affecting juice processors and importers, announced enforcement delays for Food Safety Modernization Act (FSMA)...more
Requirements take effect today under the FDA’s new Food Safety Verification Program (FSVP), which makes retailers and other businesses that import food into the United States responsible for verifying that the food has been...more
It is no secret that since the Trump Administration took over in late January, the Food and Drug Administration (FDA or agency) has been quieter than usual with regard to guidance documents and Federal Register Notices most...more
As 2017 marks the commencement of a new presidential administration, the food and beverage industry is one of many sectors facing anticipated regulatory and legislative reforms. Specifically, the industry can expect to see...more