The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more
Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more
Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more
In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more
On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more
On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more
On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more
On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more
In This Issue:
- Data for the Taking: Using the Computer Fraud and Abuse Act to Combat Web Scraping
- Google Glass Into Europe: A Small Step or a Giant Leap?
- Drugs and the Internet: FDA Distributes New...more
8/19/2014
/ ABC v Aereo ,
Accessibility Rules ,
Computer Fraud and Abuse Act (CFAA) ,
DMCA ,
EU ,
Food and Drug Administration (FDA) ,
Google Glass ,
Prescription Drugs ,
Social Networks ,
Web Scraping ,
Website Accessibility
The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more
Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance...more
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
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more
Since 2008 New Jersey law has effectively granted pharmaceutical manufacturers immunity from punitive damages claims. While New Jersey state courts continue to recognise and enforce that immunity, some recent federal court...more
Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more
Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a...more
The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more
The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more
Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more