Innovation in Compliance: Unpacking Healthcare Compliance with Maria Villanueva
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 190: Healthcare Tech and Human Resources with Shannon Frazier, HR Executive Director at Lenovo
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
Greetings and Felicitations: The Future of Healthcare…Is Now: Part 3 – The Specifics of Managing Obesity
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 153: William Kenley, CEO, and Juana Slade, Chief Diversity Officer and Director of Language Services, AnMed Health
Greetings and Felicitations: The Future of Healthcare…Is Now: Part 2- Revolutionizing Healthcare: Personalized Medicine
Private Equity VS Real Estate Transactions | #6 What’s the Best Order to Sell?
Episode 152: Matt Littlejohn, CEO, MUSC Health Midlands
Private Equity VS Real Estate Transactions | #4 Optimizing Total Asset Value
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 151: Erin Ford, EVP & COO, and David Stefanich, Board Chair, SCBIO
Private Equity VS Real Estate Transactions | #3 Real Estate Valuations Explained
AGG Talks: Home Health & Hospice - Reimbursement Audits and Appeals
Podcast - Counsel That Cares - The Value of Value-Based Cancer Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Podcast - The Latest on Antitrust and Non-Compete Agreements in Healthcare
Strategies to Manage Costs of Medical Care in a PA Workers’ Compensation Claim
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 149: Patrick Goodwill, CEO, Magnetic Insight
Podcast - Noteworthy Value-Based Care Mergers and Acquisitions Transactions
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 146: Ann Lewis, CEO, CareSouth
The Centers for Medicare & Medicaid Services (CMS) released the Part D national average bid amount and Part D base beneficiary premiums for 2025. These figures set the premium costs and government subsidies for Medicare...more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more
The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more
On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more
On April 7, 2023, two federal judges in Texas and Washington State issued dueling opinions about the abortion medication Mifepristone, just hours apart. These two decisions come in the midst of growing tension about abortion...more
The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation...more
On March 24th, 2022, the Advanced Medical Technology Association’s (AdvaMed) Board of Directors approved updates to the AdvaMed Code of Ethics (Code), which provides guidance to the health care industry on interactions...more
In a shift from prior policy, the Centers for Disease Control and Prevention (CDC) proposed on February 22, 2022, new guidelines for prescribing opioid painkillers. The new guidance largely avoids figures on dosage strength...more
Dechert partnered with Practical Law on their Q&A guide to mergers and acquisitions (M&A) in the life sciences sector, with a focus on pharma and medicines. The second part of the Q&A provides a high-level overview of the...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more
On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more
CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their...more
On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more
Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more
Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more
On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more
Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more
Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance...more