The Advanced Medical Technology Association (AdvaMed) – the national industry association of medical technology manufacturers – recently issued an updated Code of Ethics on Interactions with Health Care Professionals (HCPs) (the AdvaMed Code or Code). Last revised in 2009, AdvaMed’s
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.
Latest from Life Sciences Legal Update - Page 8
Join Us: Life Sciences Health Industry Roundtable on “Identifying and Mitigating Risk in a Changing Global Economy”
By Lisa Baird
In-house counsel at pharmaceutical, medical device, and health companies are invited to join their peers and leading Reed Smith life sciences lawyers for a roundtable discussion on how to identify and mitigate risk. The event will be held on 5…
To close out 2018, FDA published a revised draft guidance on human drug compounding for outsourcing facilities
In accordance with the United States Food & Drug Administration’s (“FDA”) 2018 Compounding Policy Priorities Plan, on December 11, 2018, FDA published its revised draft guidance regarding human drug compounding by outsourcing facilities entitled, “Current Good Manufacturing Practice—Guidance for Human…
Join Us: Free CLE Webinar on Best & Worst Drug/Medical Device Decisions of 2018
By Lisa Baird
Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2018” on Wednesday, January 16, 2019 at 12 p.m.…
FDA Announces Its Plan for Encouraging Reliance on Newer Predicate Devices and Medical Device Performance Criteria
By Emily L. Hussey & Sung Park
On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway”1 by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices as predicate devices in…
FDA to implement OIG suggestions on IoT cybersecurity
The Office of the Inspector General (OIG) published a report in September 2018 after a review of the Food and Drug Administration’s (FDA) policies, procedures, and guidance relating to cybersecurity reviews of networked medical1 devices. In its findings, covered in…
OIG Gives Stamp of Approval for Innovative Warranty Program
The Office of Inspector General (OIG) recently gave the green-light on a medical device manufacturer’s proposed warranty program, wherein the company would provide a refund to the hospital at which a patient underwent joint replacement surgery using the company’s knee…
OIG Issues RFI Regarding Federal Anti-kickback Statute and Beneficiary Inducement CMP
The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) is seeking input on Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP. The…
Brexit and the Pharmaceuticals Sector: The Key Issues
The United Kingdom (UK) is scheduled to leave the European Union on 29 March 2019. Certain key aspects of the Brexit deal now seem to have been agreed upon, including a 21 month “transitional period” after the UK’s exit, but…
Major Medical Device Changes In China Introduced by the 2018 Draft Amendment to the “Regulations on the Supervision and Administration of Medical Device”*
Following the issuance of the “Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in the Industries of Pharmaceuticals and Medical Devices” by the Central Office of the Communist Party of China and the Office of…