Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more
Headlines that Matter for Companies and Executives in Regulated Industries - Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations - Jewish Hospital & St. Mary’s Healthcare Inc. d/b/a...more
After a tumultuous year on Capitol Hill – with repeated efforts to repeal the Affordable Care Act and stalled attempts to renew the Children’s Health Insurance Program – President Donald Trump isn’t likely to focus on...more
On April 27, 2015, the U.S. Department of Health and Human Services (HHS) announced that Cornell Prescription Pharmacy (CPP), a single-location pharmacy in the Denver, Colo. metropolitan area, agreed to settle alleged HIPAA...more
On January 22, 2015, the HHS OIG released a report regarding CMS’s oversight of compounded sterile preparations (CSPs) used in hospitals. After reviewing oversight efforts at CMS and the entities that accredit hospitals to...more
The Office of the Inspector General (OIG) for HHS recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (OIG Report) in which it recommended that CMS implement changes to the way...more
The Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) included two items in its recently-released 2014 Work Plan indicating a new focus on the quality and safety of compounded...more
In This Issue: - Forecast for the Physician Payments Sunshine Act: Partly Cloudy - Document Preservation Notices and the Lists of Who Receive Them: Are They Discoverable? - FDA Warning Letters Through...more