As part of our FDA series, Reed Smith will be hosting the upcoming webinar, “FDA inspections of health care facilities: How to keep calm and carry on when FDA walks through your door” on Thursday, October 10, 2019 at 12:00 PM ET. The webinar, presented by partner Rachael Pontikes and associate Emily Hussey, will provide attendees an opportunity to join a conversation on the ins and outs of FDA inspections of health care…

On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system for drug compounding activities conducted in accordance with Section 503A of the Federal Food, Drug, & Cosmetic Act (FDCA). With this three-year pilot project, FDA’s stated hope is that it will improve the information available to federal and state regulators regarding…

As part of our Countdown to CCPA Compliance webinar series, Reed Smith will be hosting an upcoming webinar, “Countdown to CCPA compliance: 3 months to go” on Wednesday, October 9, 2019 at 2:00 PM ET. This program will explore the outcomes stemming from the September 2019 amendments on the CCPA, as well as the AG’s regulations. In addition, the webinar will include a discussion on how to keep your CCPA compliance project on a positive…

On September 23, 2019, New York-based outsourcing facility Athenex, Inc. (Athenex) withdrew its appeal of the U.S. District Court for the District of Columbia’s ruling related to the United States Food & Drug Administration’s (FDA) placement of Vasopressin on the Agency’s “clinical need” list. As may be recalled from our previous alert, Athenex sued FDA in March 2019, based on allegations that the Agency’s interpretation of key provisions of Section 503B of the Federal…

Last week marked the end of legislative activity in the state of California for 2019, and with the impending California Consumer Privacy Act (CCPA or the Act) going into effect on January 1, 2020, many businesses were waiting optimistically for some clarification on lingering questions. The California legislature did pass five bills amending the Act, presenting minimal real relief for businesses affected by this sweeping law. Some key questions remained: Would employee data be excluded?…

Entities that provide treatment to patients with substance use disorders may find some clarity on federal requirements surrounding patient record confidentiality.  The Department of Health & Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) recently announced much-anticipated proposed changes to the federal regulations at 42 C.F.R. part 2 (Part 2), which govern the confidentiality of patient records created by federally-assisted substance use disorder treatment programs (Proposed Rule).  The proposed rulemaking…