Paddle's Payment Predicament: Unpacking FTC's Compliance Crackdown — Payments Pros – The Payments Law Podcast
AI Today in 5: August 22, 2025, The Angst Episode
The Privacy Insider Podcast Episode 17: Security, Cyber-Intel, and a Sense of Humor with Nir Rothenberg of Rapyd
Daily Compliance News: August 22, 2025, The WADA Returns Edition
Regulatory Ramblings: Episode 76 - The Digital Future: The US GENIUS Act and Hong Kong Stablecoins Ordinance / The Hong Kong Web3 Blueprint: Building a Web 3 International Financial Hub Report
Point-of-Sale Finance Series: Understanding the Development and Regulation of Buy Now, Pay Later Products — The Consumer Finance Podcast
Understanding BBB Ratings: Strategic Approaches to Consumer Complaints — Regulatory Oversight Podcast
Compliance Tip of the Day: Co-Thinking with AI
Joint Venture Eligibility Refresher on Requirements for Government Contractors
Compliance into the Weeds: Two Cyber Security Cases for the Compliance Professional
The Road to Regulation: Vehicle Service Contracts Explained — Moving the Metal: The Auto Finance Podcast
AI Today in 5: August 12, 2025, The Creating Billionaires Episode
Compliance Tip of the Day - The ROI of Compliance
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
Taxing Intelligence: AI's Role in Modern Tax Administration
Podcast - An Overview of State Attorney General Consumer Protection Enforcement
LathamTECH in Focus: Move Fast, Stay Compliant
Work This Way: A Labor & Employment Law Podcast | Compliance Clarity for Federal Contractors with Joan Moore and Mim Munzel of Arbor Consulting Group
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
Compliance Tip of the Day: M&A Domestic Issues
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more
On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more
Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...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
Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...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
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more
On June 10, 2025, FDA Commissioner Martin A. Makary and Chief Medical and Science Officer Vinay Prasad published an article in the Journal of the American Medical Association titled, “Priorities for a New FDA.”1 The article...more
On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more
On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more
In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without...more
In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more
President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more
Abbreviated New Drug Applications and 505(b)(2) Applications - This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug...more
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...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 January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. It is the first new type...more
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more