Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
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
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
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 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 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
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
As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more
Featuring Francis Collins, M.D., Ph.D., Senior Advisor to President Biden and Former Director of the National Institutes of Health, and Joni Rutter, Ph.D., NCATS Director, Plus a Panel of Health Care Leaders From Pfizer,...more
In September 2021, the Office of Scientific Investigations of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued a Warning Letter to dietary supplement company RAAS Nutritionals,...more
With the ever-increasing acceptance of marijuana as a legitimate treatment for a number of medical conditions, a newfound interest in the use of psychedelics as a form of medical treatment is gaining traction once again. ...more
2020 AG Elections- A Primer on 2020 State Attorneys General Elections- •Jerry Kilgore, a Member of Cozen O’Connor’s State Attorneys General Practice and former Virginia AG and Secretary of Public Safety, penned an alert...more
Well, there he goes again (as President Reagan used to say): President Trump, whose White House has become a coronavirus hot spot and who has clearly played a role in a super spreader event, is hyping yet another medical...more
The “warp speed” race to develop a Covid-19 vaccine has gotten hit with a yellow flag....more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
The scourge of opioid-related addiction and risk is a well-known story among the pain management community. In response to this federally declared public health crisis, government prosecutors are upping their game. Almost...more
On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used “certain ‘gaming’ tactics to delay generic competition.” The list is intended to...more
The Department of Transportation (DOT) recently added four drugs at the heart of the nation's opioid epidemic to its drug testing panels: hydrocodone, hydromorphone, oxycodone and oxymorphone—the central ingredients in such...more
The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to...more
Americans’ use of prescription painkillers, anti-anxiety medications and other drugs with psychotropic effects has exploded over the past decade. Many of these medications include warnings for persons who take them with...more