FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing, and marketing of allegedly unapproved stem cell products derived from birth-related products, such as placentas, amniotic tissues, umbilical cords, and umbilical cord blood.

These products, which include human cells, tissue, and cellar and tissue-based products (also known as HCT products) are intended to treat a variety of orthopedic issues, autism, cardiac issues, dementia and arthritis. HCT products are considered “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” Examples of HCT products include “bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.”

Continue reading

Overview of Amendments to New Jersey’s Evidence Rules, Effective July 1, 2020

The increasing use of electronic discovery in litigation and the attendant high risk of inadvertent disclosures has led the New Jersey Supreme Court to adopt amendments to New Jersey’s Evidence Rule 530 (Waiver of Privilege by Contract or Previous Disclosure). The Court also adopted amendments to N.J.R.E. 608 (Evidence of a Witness’s Character for Truthfulness or Untruthfulness), and has ordered the restyling of 46 other Rules of Evidence. These amendments are effective July 1, 2020.

Continue reading

Final Drug Pricing DTC Advertising Rule to Take Effect July 9 – But Faces Challenges from Pharmaceutical Companies

This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would require pharmaceutical manufacturers to list prices in DTC advertising for drugs costing $35 for a 30-day supply.

Continue reading