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
Two recent developments at the federal level are intended to encourage more food donations. First, President Biden signed the Food Donation Improvement Act (FDIA), which expands Good Samaritan liability protections. Second,...more
In the waning days of 2022, FDA issued an updated Food Code with several important updates. FDA is responsible for more than a quarter of the U.S. economy, and the Food Code impacts virtually every American. Originally...more
On October 4th, the FDA and CDC announced that the agencies have entered into a Memorandum of Understanding, renewing their collaboration to reduce the occurrence of foodborne illness in retail and foodservice establishments....more
The introduction of meal delivery apps, including UberEats, GrubHub and DoorDash, has expanded e-commerce in the food industry and increased the size of the food delivery market. Over the last five years prior to the start of...more
In the wake of the COVID-19 pandemic in the United States, the U.S. Food and Drug Administration in March relaxed its labeling requirements for food manufacturers and restaurants to aid the distribution and sale of food...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Reopening Guidelines for Food Establishments - The U.S. Food and Drug Administration (FDA) has published a food-safety checklist for retail food establishments that...more
The U.S. Food and Drug Administration (FDA) has issued two resources for retail food establishments that are reopening after closing or partially closing in response to COVID-19. The resources include a Food Safety Checklist...more
The COVID-19 pandemic has dramatically changed how the retail end of the food industry (restaurants and grocery) interact with consumers. In most states the restaurant industry has been forced to limit their offerings to...more
This post summarizes two recent steps by the federal government to provide food safety guidance in response to the COVID-19 outbreak. First, the U.S. Food and Drug Administration (FDA) has issued a fact sheet and...more
This post summarizes two recent steps by the federal government to provide food safety guidance in response to the COVID-19 outbreak. ...more
The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the...more
This memorandum summarizes recent actions the U.S. Food and Drug Administration (FDA) has taken in response to the COVID-19 outbreak. First, FDA has issued a temporary policy to provide flexibility to chain restaurants and...more
The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited...more
Restaurant owners may be wondering how the FDA’s new produce safety regulations affect them. Through these new regulations, the FDA has attempted to tackle the growing number of outbreaks involving produce traditionally...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
On July 22, 2019, the U.S. Food and Drug Administration (FDA) suspended the food facility registration of Topway Enterprises Inc.'s (Topway) Houston, Texas seafood processing facility. As a result, Topway cannot sell or...more
Shook Takes the Pulse of General Counsel on Maturation of Global Cannabis Market - More than half of in-house counsel surveyed in a new white paper by Shook, Hardy & Bacon plan to increase legal spending in the next two...more
LEGISLATION, REGULATIONS & STANDARDS - CBD Banned from New York Restaurants, in Limbo in Idaho - New York City’s health department has reportedly ordered restaurants to stop serving products that contain cannabidiol...more
Food Safety News reported on the FDA’s use for the first time of mandatory recall power. QSR discussed ways restaurants are fighting food waste. The Conversation reported on regulation of urban poultry....more
US, EU Near Agreement on Shellfish Trade - The U.S. Food and Drug Administration (FDA) has proposed to allow the import of raw bivalve molluscan shellfish—including clams, mussels, oysters and scallops—harvested in the...more
The U.S. Food and Drug Administration (FDA) is soliciting public comment on whether the agency should continue to collect information about foodborne illnesses in restaurants. The proposal would extend studies of risk...more
On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain...more
OIG Report Suggests Improvements to FSMA Enforcement - A report from the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services has concluded that the Food and Drug Administration (FDA)...more
FDA Announces Final FSMA Produce Safety Rule - The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing...more
GE Salmon Bill Introduced in U.S. Senate - A bipartisan group of U.S. senators has introduced a bill that would require labeling of genetically engineered (GE) salmon and independent scientific review of the U.S. Food and...more