Searching Content indexed under Food and Drugs Law by Julie Park ordered by Published Date Descending.
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Committed To Clarity: FDA's Dedication To Transparency With The End Of ASR
On June 21, the Food and Drug Administration (FDA) released a report titled "Statement on agency's efforts to increase transparency in medical device reporting."
United States
15 Jul 2019
Supreme Court Decides Prescription Drug Preemption Case In Favor Of Drug Manufacturer
The United States Supreme Court finally clarified its 11-year-old "clear evidence" standard for pharmaceutical preemption.
United States
13 Jun 2019
3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing
In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices.
United States
17 Jan 2018
Makeup Shake Up: Potential New Federal Cosmetics Regulations
"Make fine lines and wrinkles disappear!" "Reduce the visibility of fine lines and wrinkles!"
United States
5 Jan 2018
Bristol-Myers Squibb: The Aftermath
Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco City.
United States
17 Aug 2017
FDA's Denial Of Citizen's Petition "Clear" Enough For Preemption Of Failure-To-Warn Claims
The Tenth Circuit recently upheld a Utah district court's finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA...
United States
21 Jul 2017
Trump's Nominee For FDA Commissioner Likely Dooms Generic Drug Labeling Rule
President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA's proposed generic drug labeling rule.
United States
7 Apr 2017
Trump's Nominee For FDA Commissioner Likely Dooms Generic Drug Labeling Rule
President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA)...
United States
6 Apr 2017
FDA Releases Draft Guidance For Updating Generic Drug Labels
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels.
United States
25 Jul 2016
Still Waiting—FDA Delays Rulemaking
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations
United States
22 Jun 2016
Defendants Secure Rare Summary Judgment In Zoloft MDL
In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants' motion for summary judgment as to over 300 cases in the Zoloft MDL.
United States
9 May 2016
Federal Preemption Claims: Clear Evidence And An Unclear Standard
Last week, a federal court in Utah granted Aventis Inc.'s motion for summary judgment based on federal preemption of failure-to-warn claims.
United States
6 Apr 2016
Liability For Brand Drug Manufacturers All But Clear
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...
United States
3 Mar 2016
New Settlement Highlights FDA's Diminishing Power Over Off-Label Promotion
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 drugs.
United States
31 Dec 2015
Sixth Circuit Sweeps State-Law Design Defect Claims Under The Rug Of Impossibility Preemption
Yates is the first federal appellate authority to recognize "impossibility preemption" of design defect claims against brand-name drug manufacturers.
United States
23 Dec 2015
Alabama Legislature Says No To Innovator Liability
On April 29, 2015, the Alabama Senate passed a bill, SB80, "to provide that a manufacturer is not liable . . . for damages resulting from a product it did not design, manufacture, sell, or lease." Sponsored by Senator Cam Ward, the bill supersedes the Alabama Supreme Court’s controversial holding in Wyeth, Inc. v. Weeks, No. 1101397, 2014 WL 4055813 (Ala. Aug. 15, 2014).
United States
6 May 2015
Generic Drug Manufacturers To Face Failure-To-Warn Claims In California
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, 2015).
United States
2 Feb 2015
Weeks II: Innovator Liability Finds A Sweet Home In Alabama
Last week, the Supreme Court of Alabama confirmed its January 2013 holding that manufacturers of brand drugs can be liable for injuries caused by generic drugs.
United States
2 Sep 2014
Launch Of OpenFDA Increases Accessibility To Adverse Drug Event Reports
The Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports.
United States
7 Jul 2014
$4 Billion Price Tag For Pleasing Plaintiffs' Bar? New Study Estimates Costs Of FDA's Proposed Rule On Generic Drug Labeling
An economic consulting group recently published findings that a FDA proposed rule will increase annual healthcare costs by $4 billion.
United States
10 Mar 2014
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