Medical Device Legal News with Sam Bernstein: Episode 18
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
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...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On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs.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
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
It was Mental Health Day under the Gold Dome, headlined by the unveiling of Speaker David Ralston’s (R-Blue Ridge) much discussed, and anticipated, mental health parity bill. House lawmakers, members of the Behavioral Health...more
In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more
In Washington: President Biden on Thursday doubled to 200 million his administration’s goal for the number of COVID-19 vaccination shots to administer in his first 100 days in office. The U.S. is set to reach Biden’s original...more
In Washington: The House Budget Committee approved legislation for a $1.9 trillion coronavirus relief package on Monday evening, with a full House vote is expected at the end of this week. So far, House Democrats expect a...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: The federal government’s role in physically distributing COVID-19 vaccines remains unclear. President Trump said last month that the military would distribute vaccines. But a spokesman for Operation Warp...more
In Washington: House Speaker Nancy Pelosi (D-CA) in a Thursday morning letter to Treasury Secretary Steven Mnuchin pressed the White House for a response to the Democrats' latest coronavirus relief package proposal....more
In Washington: White House communications director Alyssa Farah said Tuesday that the White House still hopes for a coronavirus relief package, probably post-election. Speaking on Fox & Friends, Farah said President Trump...more
In Washington: Tuesday afternoon, House Speaker Nancy Pelosi (D-CA) said Democrats and the White House have moved closer to a deal on a fourth COVID-19 stimulus relief bill ahead of her latest call with Treasury Secretary...more
In Washington - Secretary Steven Mnuchin and Speaker Nancy Pelosi spoke for an hour Wednesday morning and plan to speak again tomorrow. Mnuchin says they continue to “make progress” while Pelosi’s spokesperson says the...more
In Washington - White House Chief of Staff Mark Meadows has “drawn his line in the sand” on a new coronavirus relief bill during an interview on NBC’s Meet The Press Sunday, saying the Trump administration is standing...more
In Washington - The House of Representatives, in a 257-150 vote, passed legislation providing US$25 billion to the United States Postal Service and bans any operational changes to the agency, while reversing...more
In Washington - House Speaker Nancy Pelosi (D-CA) is calling Democrats back from the August recess to vote on legislation that would prohibit operational changes at the U.S. Postal Service that could curtail mail-in...more
In Tuesday's Report: changes in Italian trademark law; new insolvency trends in China; tips for corporate boards to prepare for crisis; potential conflicts of interest in U.S. COVID-19 contracts, and other Congressional...more
In Washington - Senate Majority Leader Mitch McConnell (R-KY) is planning to hold floor votes on unemployment benefits forcing Democrats to go on the record as coronavirus relief bill talks stall. Floor votes are a...more
In Washington - Senate Majority Leader Mitch McConnell (R-KY) introduced the “Health, Economic Assistance, Liability Protection, and Schools Act” (HEALS Act). The Republican proposal includes several provisions designed to...more
In Washington: Just as some federal agencies are calling for federal employees who are teleworking to return, several Virginia and Maryland lawmakers are warning that it might be too early. ...more
In Washington: Today, the House will meet for a pro forma session and the Senate will resume consideration of John Badalamenti to be United States District Judge for the Middle District of Florida. The full House will be...more
In Washington - The House will meet for a pro forma session on Monday and the full House is out of session next week. The Senate will reconvene on Monday and resume consideration of John Badalamenti to be United States...more
In Washington - The House will be in session on Wednesday and Thursday and is expected to vote on two bills dealing with the Paycheck Protection Program (PPP) giving small businesses more flexibility in the use of the...more
How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal "Right to Try" - As discussed in our Alert of June 4, "Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers,...more