Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
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
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
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
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more
Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more
Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more
U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...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
It seems like every day I read a new story about legislators, high-ranking federal officials, and frustrated advocates of marijuana research complaining that researchers still can't study the actual marijuana that people are...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more
Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more
Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more
On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more