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Mintz - Health Care Viewpoints

FDA Greenlights Updates to the Purple Book Database

Mintz - Health Care Viewpoints on

As promised, the Food and Drug Administration (FDA) updated the Purple Book: Database of FDA-licensed Biological Products, providing greater transparency and more user-friendly search functionality for the biological product...more

Polsinelli

Changes Coming For Prescribers To The Texas Prescription Drug Monitoring Program

Polsinelli on

In response to the opioid epidemic, many states, including Texas, created prescription drug monitoring programs to monitor high-risk patients and provider behaviors. The Texas Prescription Drug Monitoring Program (“PMP”) is...more

Hogan Lovells

FDA finalizes guidances for NGS-based tests

Hogan Lovells on

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more

Jones Day

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

Foley & Lardner LLP

Forget Bigger Data – Personalized Medicine Needs Smarter Data to Reach its Full Potential

Foley & Lardner LLP on

The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter...more

Hogan Lovells

EMA Update concerning EU Clinical Trials portal and database

Hogan Lovells on

Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The...more

Searcy Denney Scarola Barnhart & Shipley

FDA Adverse-Event Reports Go Public

Searcy Denney Scarola Barnhart & Shipley on

Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...more

Morrison & Foerster LLP

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

Morrison & Foerster LLP on

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Patrick Malone & Associates P.C. | DC Injury...

Grand Opening of openFDA.gov

Patrick Malone & Associates P.C. | DC Injury... on

Information is power, and as of this month, there’s a new power source of information about drug effects. openFDA.gov is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of...more

Faegre Drinker Biddle & Reath LLP

FDA Launches Huge Online Database of Adverse Events

Faegre Drinker Biddle & Reath LLP on

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

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