Reed Smith will be hosting an upcoming webinar, “12 Months in Health Care Law: A Roller Coaster Journey”, on Tuesday, October 15, 2019 at 12:00 PM ET.
The webinar will deliver an informative and entertaining review of many of the
Life Sciences Legal Update
Analysis & commentary by Reed Smith on trends & developments in life sciences & health care law
Life Sciences Legal Update, published by Reed Smith LLP, focuses on legal developments affecting multinational and global life sciences companies. The blog covers topics such as regulatory guidance from agencies like the FDA, product recalls, patent law issues including AI inventorship, and compliance with evolving healthcare and pharmaceutical regulations. It also addresses litigation trends, industry-specific legislative changes, and risk management strategies relevant to drug and medical device manufacturers. The blog serves as a resource for legal professionals and industry stakeholders seeking updates on the intersection of law and life sciences business operations.
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Join us for a webinar covering FDA inspections of health care facilities: How to keep calm and carry on when FDA walks through your door
By Lisa Baird
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…
FDA Partners with the National Association of Boards of Pharmacy to Create an Information-Sharing System for Drug Compounding Activities
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…
Join us for a webinar on the state of the California Consumer Privacy Act and what the latest amendments mean for you.
By Lisa Baird
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…
New California ballot initiative would expand protections over health data
Californians may have a new privacy initiative on their November 2020 ballot after the California Privacy Rights and Enforcement Act of 2020 (CPREA) was proposed last week. If enacted, this new law would revise and expand upon the California Consumer Privacy…
Outsourcing Facility Athenex Withdraws Appeal of District Court’s Ruling on FDA’s Placement of Bulk Drug Substances on its “Clinical Need” List
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…
Key questions linger after recent amendments to California Consumer Privacy Act
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…
Proposed Rule Offers Clarity on Mandatory Protections for Substance Use Disorder Patient Records
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…
Recent Traction In FDA’s Development of the 503A and 503B Bulks Lists
Just as the U.S. Food & Drug Administration (“FDA”) promised in its 2019 compounding priorities statement, FDA published a notice and proposed rule in the Federal Register in the past week related to bulk drug substances that can be compounded…
Join us for a webinar on the changing regulatory landscape of promotion: Drug/biologic advertising in the Trump era and beyond
By Lisa Baird
As a part of our FDA Series, Reed Smith will be hosting an upcoming webinar, “The changing regulatory landscape of promotion: Drug/biologic advertising in the Trump era and beyond” on Thursday, September 19, 2019 at 2:00 PM ET.…