The Informed Board Podcast | Board Oversight at a Time of Political and Geopolitical Uncertainty
Podcast - Tips for Maintaining FTC Compliance When Using AI
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
From Banks to FinTech: The Evolution of Small Business Lending — The Consumer Finance Podcast
From Banks to FinTech: The Evolution of Small Business Lending — Payments Pros – The Payments Law Podcast
Podcast - Navigating the Updated SF-328 Form
Five Tips for a New Public Company Director
Doc Fees Decoded: The Price of Paperwork in Auto Sales — Moving the Metal: The Auto Finance Podcast
PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions
Episode 371 -- DOJ's New Corporate Enforcement Program
Podcast - New Guidance on Complying with FTC Rule on Deceptive and Unfair Fees
Welcoming a New Payment Pro: Jason Cover Joins the Payments Pros Podcast — Payments Pros – The Payments Law Podcast
(Podcast) The Briefing: Influencer Fail – ALO Yoga & Influencers Named in $150M Class Action Lawsuit for FTC Violations
The Briefing: Influencer Fail – ALO Yoga & Influencers Named in $150M Class Action Lawsuit for FTC Violations
Compliance into the Weeds: Leaving on a (Qatari) Jet Plane
LEGAL ALERT | NAD Finds Kevin Hart’s Social Media Disclosures Insufficient in Monitoring Decisions
Choosing Your LDA Reporting Path for 2025
Bar Exam Toolbox Podcast Episode 305: Spotlight on Civil Procedure (Part 2 – Discovery)
Compliance Tip of the Day: Clarifying Compliance Mandates
Consumer Finance Monitor Podcast Episode: How to Use the Restatement of Consumer Contracts - A Guide for Judges
The U.S. Food and Drug Administration (FDA) on Sept. 4, 2025, announced the release of 89 previously unpublished Complete Response Letters (CRLs), building on the previous release of more than 200 CRLs on July 10, 2025. The...more
On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination for refusing to approve a...more
In Sneed v. Talphera, Inc., 2025 WL 2406424 (9th Cir. Aug. 20, 2025), the United States Court of Appeals for the Ninth Circuit affirmed the dismissal of a securities fraud suit against Talphera, Inc. (formerly AcelRx...more
The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more
The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more
The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more
On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more
This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more
The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a “lighter touch” when it comes to enforcement. The ultimate approach of the new SEC...more
Celebrity Endorsements - As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms....more
In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more
Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more
HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more
On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
On December 27, President Biden signed the Preventing Organizational Conflicts of Interest in Federal Acquisition Act into law. The legislation, ushered through Congress by a bipartisan group of backers, strengthens existing...more