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- Feed Preview | Life Sciences Legal Update
U.S. Court of Appeals rules AI cannot be named an inventor
According to the U.S. Court of Appeals for the Federal Circuit’s August 5th ruling in Thaler v. Vidal, No. 2021-2347 (Fed. Cir. 2022), artificial intelligence (“AI”) cannot be named as an i...
FDA finalizes guidance on voluntary recalls, issues recommendations for industry
The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how...
Health care workers and private employees could be affected by new CMS interim final rule and OSHA final rule
On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule that requires vaccinations for certain health care workers. The rule is limited to only t...
Here we go again – Unified Patent Court back on track
The German Constitutional Court issued a landmark decision with implications for many companies doing business in Europe on July 9, 2021. For decades, the European Commission and EU member states...
German Patents Act (PatG) Receives New Updates
Germany recently passed a reform bill for the Patent Act (PatG) and its new provisions will likely be coming into force sooner rather than later. The reform is particularly relevant for companies...
A multi-agency pharmaceutical task force looks to review antitrust issues that arise during mergers and acquisitions
A task force, composed of key antitrust enforcement agencies including the Federal Trade Commission (FTC), and the Canadian Competition Bureau, is seeking information from the public regarding th...
HHS Reconsiders Penalty Structure for HIPAA Violations, Imposes Annual Limits based on “Level of Culpability”
On Friday, April 26, 2019, the U.S. Department of Health and Human Services (“HHS”) filed a Notice of Enforcement Decision (the “Notice of Enforcement”), confirming the agency’s reconsi...
FDA Issues 2019 Goals to Improve The Quality of Compounded Drugs
Just prior to departing the FDA (U.S. Food and Drug Administration) Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram issued a statement (the “Statement”) on the Agency’...
AdvaMed Issues Revised Code of Ethics on Interactions with U.S. Health Care Professionals
The Advanced Medical Technology Association (AdvaMed) – the national industry association of medical technology manufacturers – recently issued an updated Code of Ethics on Interactions with ...
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 h...