Medical Device Legal News with Sam Bernstein: Episode 18
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 Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more
In recent years, an unprecedented level of interest in the promise of psychedelics has taken hold. In the United States, many types of psychedelics are being investigated for use in treating an array of mental health...more
On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more
In Washington: Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky urged parents to vaccinate adolescents and teenagers against the coronavirus Friday, adding that COVID-19 can be severe for this age...more
In Washington: The House of Representatives was set to pass its $1.9 trillion pandemic relief package (H.R. 1319), late Friday night over solid Republican opposition. The passage is a key step toward giving President Joe...more
In Washington: The Senate resumed former President Trump’s impeachment trial Wednesday. House impeachment managers presented a step-by-step timeline of the January 6 assault on the Capitol aided by new evidence. Senators saw...more
In Washington: With only hours to spare, House and Senate lawmakers were forced to pass a last-minute short-term extension of government funding (H.J. Res. 107) to stave off a government shutdown while congressional...more
In Washington: Top Senate Republicans indicated on Thursday that Congress is increasingly likely to need a brief stopgap government funding bill lasting several days to clinch a spending and coronavirus relief deal. Friday...more
In Washington: The “four corners”— House Speaker Nancy Pelosi (D-CA), House Minority Leader Kevin McCarthy (R-CA), Senate Minority Leader Chuck Schumer (D-NY), Senate Majority Leader Mitch McConnell (R-KY)—are reportedly...more
In Washington: The Senate passed a one-week stopgap bill on Friday, hours ahead of a government shutdown deadline. The bill passed on a voice vote and moved the funding deadline to December 18. The continuing resolution...more
In Washington: The Food and Drug Administration’s (FDA) vaccine advisory panel voted to recommend that the FDA authorize the Pfizer-BioNTech vaccine for emergency use. A Centers for Disease Control and Prevention (CDC)...more
In Washington: Congress continues to debate a new coronavirus relief package, possibly as part of a government spending bill due December 11. Here are the latest developments...more
In Washington: Two Treasury Department moves in recent days are generating controversy among lawmakers and policymakers: Treasury Secretary Steven Mnuchin announced Thursday that he will not extend the Federal...more
In Washington: Wednesday, the House held its leadership elections reelecting Rep. Nancy Pelosi (D-CA) as Speaker of the House by her caucus. Other top Democratic leaders, Majority Leader Steny Hoyer (D-MD) and Majority...more
In Washington: Two public health experts on President-elect Biden’s COVID-19 task force rejected the idea of broad “lockdowns” like those seen in the spring designed to slow skyrocketing case numbers. Celine Gounder told...more
In Washington: President Trump left Walter Reed Medical Center Monday evening despite his personal doctor, Sean Conley, saying he “may not be entirely out of the woods yet.” In a memo on Tuesday, his doctor said the...more
In Washington - Senator Bill Cassidy (R-LA) has tested positive for coronavirus. Cassidy took a test on Thursday evening after being informed that he had been exposed to an individual with COVID-19. He is quarantining for...more
Louisiana is expanding medical marijuana, and the United Nations may reschedule cannabis. Meanwhile, PetSmart faces a lawsuit over pet CBD. MedMen has campaign finance problems, and the 9th Circuit looks at taxes....more
In Washington: The House schedule is still up in the air and there is no new information on when Democrats will release their draft of the new coronavirus stimulus legislation....more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more
Letters and Statements - Gene Therapy: Democratic Senators Urge the FDA to Hold Company Accountable for Falsifying Data - On August 9, 2019, a group of Democratic senators, including two presidential candidates, sent...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more
On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients with life-threatening conditions the right to...more