California Regulation of Charitable Fundraising Platforms Part 2 - Reporting Due Diligence, Recordkeeping, and Disclosure Rules
Episode 312 -- Eddie Green, CEO SnippetSentry, on Communications Preservation Risks
Episode 298 -- Electronics Communications Risks and Ephemeral Messaging
A Look Into the FDA and USDA Regulatory Regimes
Nonprofit Basics: Meeting Minutes Best Practices
The Risk Roundtable: Best Practices for Litigation to Help After an Accident
PLI's inSecurities Podcast - Compliance and Enforcement Considerations for Private Funds & RIAs
California Employment News: Best Practices for Maintaining Employee Records
OSHA Recordkeeping Regulations: Understanding the Fine Print
FLSA and Wage and Hour Issues for Restaurants
#WorkforceWednesday: OSHA Updates COVID-19 Guidance, NLRB GC’s Priorities, Biometrics at Work - Employment Law This Week®
[Webinar] Common Massachusetts Cannabis Business Compliance Pitfalls
Risk Prevention Strategies: Avoiding Costly FLSA Missteps
How to Navigate the After Effects of the U.S. Stimulus Packages
Regulation Best Interest Videocast Series: Regulation BI Recordkeeping Requirements
Podcast: Private Fund Regulatory Update – Network and Cloud Storage
On October 8, 2023, Governor Gavin Newsom signed Assembly Bill 1286 (AB 1286), a sweeping pharmacy measure with several components aimed at promoting patient safety. Chief among AB 1286’s mandates is a new law requiring that...more
History of 401(k) Plan Excessive Fee Cases. Once the Department of Labor’s participant fee disclosure rules for retirement plans became effective in 2012, the plaintiffs’ bar latched onto recordkeeping and investment fees...more
Would Require In-Person Examination In Many Prescribing Scenarios - Almost fifteen years ago, Congress amended the Controlled Substances Act (CSA) to reduce illegitimate, Internet-based access to controlled drugs while, at...more
On February 24, 2023, the Drug Enforcement Agency announced proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The proposed rules are open for public...more
It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more
The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency. The Prescription Drug Marketing Act of 1987 (PDMA)...more
In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more
On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more
In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more
The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more
Note: This is a companion piece to our parallel article discussing the various Delaware commercial insurance coverage requirements in the Act. Delaware Gov. Jack Merkell signed into law, on July 7, 2015, a bill...more
Last week, the Generic Pharmaceutical Association (GPhA) released a statement regarding a California bill (SB-598) that the GPhA asserted would "introduce[] burdensome provisions that could raise costs and limit patient...more