News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Transparency

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

Dechert LLP on

Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

King & Spalding

FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?

King & Spalding on

First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Holland & Knight LLP

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

Holland & Knight LLP on

Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more

Mintz - Health Care Viewpoints

HHS Files Brief in D.C. Circuit Supporting Drug Pricing Transparency Rule

As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the...more

Bergeson & Campbell, P.C.

EPA’s OCSPP Agrees to More Communication, Transparency, and Efficiency When Processing Pesticide Petitions

On October 27, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs Policies and Procedures to Manage Public Pesticide...more

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