Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
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
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more
Responding to Law Enforcement and Safeguarding Your Interests - In this final installment of our series on government investigations, we tackle the most daunting scenario: the execution of a search warrant at your...more
Understanding Your Obligations and Protecting Your Rights - Government investigations are a reality for businesses operating in FDA-regulated industries. While the previous webinar focused on general preparedness, this...more
Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more
Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more
Proving access to and use of trade secrets are core elements in a trade secrets misappropriation case. Recent rulings in a trade secrets action filed by Allergan against its competitor Revance Therapeutics (“Revance”)...more
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program designed to help attendees increase their ability to manage effective compliance programs. Our faculty of experts provides...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...more
On November 4, 2021, the Occupational Safety and Health Administration (OSHA) released its highly anticipated emergency temporary standards for COVID-19 (the “ETS”) along with a landing page on its website with various...more
As of Monday, restaurants, bars, malls, gyms, yoga studios, movie theaters, sports arenas, hair salons and many other businesses in Los Angeles must begin requiring that patrons show proof of vaccination for COVID-19 before...more
Less than two months after receiving direction from President Joe Biden, the Occupational Safety and Health Administration (OSHA) has issued an Emergency Temporary Standard (ETS) covering employers with at least 100...more
New York City’s Key to NYC mandate for indoor dining, gyms and entertainment venues is now in effect. Below are the requirements of the mandate as set forth in the various Executive Orders that have been issued, as well as in...more
On September 17, 2021, the Safer Federal Workforce Task Force (the “Task Force”) issued updated guidance (the “Guidance”) to federal agencies about COVID-19 safety protocols for employees of federal contractors and federal...more
May an employer require its California employees to be vaccinated against COVID-19? According to recent guidance from the state Department of Fair Employment and Housing, the short answer is yes. On March 4, the DFEH...more
A welcome clarification. May an employer require its California employees to be vaccinated against COVID-19? According to recent guidance from the state Department of Fair Employment and Housing, the short answer is yes....more
HCCA's Health Care Research Compliance Academy is a three-and-a-half-day intensive training program focuses on compliance issues related solely to research. Its faculty is made up of experts in the field. With a wide range of...more
A new guidance document from the FDA lists considerations and suggested steps to reduce the likelihood of cybersecurity breaches in medical devices....more