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
The U.S. Senate is in session for three days this week while the U.S. House of Representatives is in recess all week. Both chambers will return for a week before breaking for the July 4 recess. Negotiations on the...more
U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more
U.S. Congress returns from a two-week recess this week and has lofty goals to draft, mark up and pass a reconciliation bill by Memorial Day 2025. The U.S. House of Representatives Committee on Energy and Commerce, which was...more
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
In 2024, the federal government continued to shape the research compliance landscape with significant developments for research institutions across several areas. Key updates included the continued implementation of research...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
On April 30, 2024, the Associated Press reported a significant development in cannabis policy: the U.S. Drug Enforcement Administration (“DEA”) is recommending reclassifying cannabis from Schedule I to Schedule III. This...more
Following an initial funding announcement last month, the Biden administration has kept its foot on the gas to build out the White House Initiative on Women’s Health Research. Last month, we wrote about ARPA-H’s $100 million...more
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document named Enhancing...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance titled “Key Information and...more
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When...more
Last week, the Department of Health and Human Services (HHS) released the full text of its letter (HHS Letter) to the Drug Enforcement Administration (DEA), recommending marijuana rescheduling from Schedule I to Schedule III....more
In October 2022, President Biden asked the Department of Health and Human Services (HHS) and the Attorney General to review how marijuana is scheduled under federal law. In August 2023, the HHS marijuana recommendation went...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more
Major news broke on August 30, 2023, as the U.S. Department of Health and Human Services (HHS) announced that it would recommend moving marijuana from Schedule I to Schedule III, as first reported by Riley Griffin for...more
Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more
The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more
Report on Research Compliance 18, no. 12 (December, 2021) - A month after rumors circulated that President Biden planned to tap former Food and Drug Administration (FDA) Commissioner Robert Califf to serve again, the...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