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
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
This week, the U.S. Food and Drug Administration (FDA) issued final guidance concerning regulatory oversight of food imported from Systems Recognition Arrangement (SRA) countries. FDA employs a Systems Recognition (SR)...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
On October 22, 2021, the U.S. Food and Drug Administration (FDA) published an update on its efforts to assist US companies on China’s implementation of a new registration requirement for all food facilities importing foods...more
The U.S. Food and Drug Administration (FDA) recently issued a review of work done over the last year in advancing its New Era of Smarter Food Safety (New Era) Blueprint, which was released in July 2020. In a corresponding FDA...more
Maybe it’s a product that you’ve imported into the U.S. dozens of times. Maybe this is your first time importing this product or you’re working with a new business partner. Maybe you’re very familiar with the process, or...more
FDA Enters New Phase Of FSVP Enforcement - The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due...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
On April 3, 2020, the Food and Drug Administration (FDA) issued a Constituent Update notifying the public that for Foreign Supplier Verification Program (FSVP) inspections, FDA requests importers electronically send records...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
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 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) regulation....more
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues First Warning Letter for FSMA Foreign Supplier Program - The U.S. Food and Drug Administration (FDA) has issued the first warning letter enforcing the Food Safety...more
In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first...more
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA...more
In her report on the 2008 Canadian listeriosis outbreak, Independent Investigator Sheila Weatherill highlighted the need for “substantial consolidation and modernization” of the legislative and regulatory framework governing...more
The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier...more
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics: - Guidance on application of the Foreign Supplier...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
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
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