Executive Actions Impact Federally Funded Research: What Institutions Should Do Now – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 215: Bioactives for Human Health with Jan-Willem van Klinken of Brightseed
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Wiley's 10 Key Trade Developments: The CHIPS Act and Inflation Reduction Act (IRA)
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely Teasdel, Deputy Secretary of SC Department of Commerce
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 180: SCBIO and the Life Sciences Industry in South Carolina with James Chappell, SCBIO CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim Dall, Healthcare Economist
Stoel Rives | Deeply Rooted Podcast S3E3: AgTech Innovation and Robotics with Burro CEO Charlie Andersen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 166 — Christine Vannais, COO of Fujifilm Diosynth Biotechnologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Delivering Successful Research Projects: What Legal Marketers Need to Know - Passle's CMO Series Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 154: Andy Schwartzkopf, General Counsel and Chief Administration Officer, Signature Medical Group
Business Better Podcast Episode: Accelerating Life Sciences: How Accelerators and Education Are Joining Forces to Catapult the Life Sciences Industry
The 'Secrets' of Trade Secrets in Government Contracting
What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more
On Feb. 13, moments after Robert F. Kennedy Jr. was confirmed as secretary of health and human services, President Donald Trump issued his first health care Executive Order (EO) under new leadership, laying the groundwork to...more
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more
Last week, Acting Secretary of the US Department of Health and Human Services (HHS) Dorothy Fink instructed federal health agencies within the HHS to freeze all external communications, including health advisories, weekly...more
Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...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
The U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first draft guidance on clinical trials involving...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more
The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...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
After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more
Report on Research Compliance 19, no. 10 (October, 2022) - Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...more
In late July, the U.S. House of Representatives passed H.R. 8454, the Medical Marijuana and Cannabidiol Research Expansion Act (Research Expansion Act). A similar version of the bill, S. 253, passed the Senate earlier this...more
On Thursday, March 24, 2022, the Senate unanimously passed the CMRE Act (Cannabidiol and Marihuana Research Expansion Act) and House leadership scheduled the MORE Act (Marijuana Opportunity and Expungement Act) for a floor...more
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...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
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...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
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
President Donald Trump on February 12, 2018, submitted his budget request to Congress for Fiscal Year (FY) 2019. The President's full budget calls for approximately $4.4 trillion in total spending. Much of the budget seeks...more
Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...more
A complex—and occasionally, inconsistent—patchwork of federal and state regulatory requirements apply to entities that perform human subjects research in the United States. In recognition of one such inconsistency, the...more