Employment Law Now VIII-150 - The FTC Noncompete Rule is Dead: What Now?
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Sustainable Procurement: A Closer Look at the New Federal Acquisition Regulation (FAR)
Employment Law Now VIII-145 – Status Update: Injunctions for FTC Non-Compete Ban and DOL Overtime Exemption Regs
Legal Alert | Reign It In: Federal Court Enjoins DOL's Expansion of Davis-Bacon Coverage
Consumer Finance Monitor Podcast Episode: What Banking Leaders Need to Know About the U.S. Supreme Court Ruling That the CFPB’s Funding Mechanism is Constitutional Part I
Unpacking FERC's Transmission Planning and Permitting Final Rules
The Burr Broadcast: Key Differences Between PWFA and ADA
DOL’s Expanded Overtime Salary Limits, EEOC’s Sexual Harassment Guidance, NY’s Mandatory Paid Prenatal Leave - Employment Law This Week®
The FTC Issued a New Rule to Ban All New Noncompete Agreements
Preparing for Major Changes to DOT’s Disadvantaged Business Enterprise DBE Program
#WorkforceWednesday: FTC Nixes Non-Competes Nationwide—Now What? - Employment Law This Week® - Spilling Secrets Podcast
Fierce Competition Podcast | Understanding the FTC’s Landmark Ban on Noncompetes
Meeting the Proposed SEC Climate Disclosure Requirements
Consumer Finance Monitor Podcast Episode: A Close Look at the Consumer Financial Protection Bureau’s Final Credit Card Late Fee Rule: Have Cardholders Been Dealt a Winning or Losing Hand?
What's the Tea in L&E? Alert: Salary Threshold for Exempt Employees Increases to $58,656
What's the Tea in L&E? Alert: Non-Compete Agreements Largely Banned by New FTC Rule
#WorkforceWednesday: SCOTUS Expands Title VII, EEOC’s Final PWFA Rule, AI Screening Tools - Employment Law This Week®
The CFPB's Final Credit Card Late Fee Rule: Implications and Industry Response — The Consumer Finance Podcast and Payments Pros: The Payments Law Podcast
Successor Government Contractor Hiring Obligations Change: DOL’s Long Awaited Nondisplacement Rule
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about...more
The Centers for Medicare & Medicaid Services (CMS) published an interim final rule implementing the Most-Favored-Nation (MFN) Model for Medicare Part B drugs and biologics in the November 27, 2020, Federal Register (the...more
Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more
On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” ...more
On February 21, the FDA published a final rule in the Federal Register that implemented a requirement of the BPCIA, transitioning insulin, and some other products such as human growth hormone (somatropin), pancrelipase,...more
The FDA recently issued a final rule regarding the definition of “biological product,” amending its previous definition. The statutory definition of “biological product” included “protein (except any chemically synthesized...more
The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. ...more
On May 10, 2019, the Centers for Medicare and Medicaid published a Final Rule on drug pricing transparency in consumer advertisements. ...more
On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule to revise regulations and clarify program requirements within the Medicare Advantage (MA) and the Prescription Drug Benefit (Part D)...more
As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more
On January 11, 2017, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled “Current Good Manufacturing Practice Requirements for Combination Products.”[1] This guidance describes and explains...more
On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more
The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more
This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more