. . . Try, Try Again; But Enough is Enough
Is what the court finally had to tell plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2023 U.S. Dist. LEXIS 166742 (C.D. Cal. Sep. 19, 2023) in…
Source: lexology.com
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Some Welcome Clarity on Preemption | Reed Smith
Every once in a while in this space we summarize law review articles. In the course of doing so, we typically pat ourselves on the back by announcing that we read such articles so that...
Reed Smith Pharmaceutical Preemption Public Policy Big Pharma Changes Being Effected Solicitor General
Source: jdsupra.com
Lack of "Newly Acquired Information" Defeats Plaintiffs' Claims in Zofran MDL | Faegre Drinker Biddle & Reath LLP
Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an...
United Kingdom Faegre Drinker Biddle Reath Boehringer Ingelheim Pharms Inc Faegre Drinker Biddle First Circuit Products Liability Litigation
Source: jdsupra.com
Court Denies Motion to Dismiss Claims Targeting a Biologic
The decision we report on today, Frye v. Novartis Pharms. Corp., 2022 WL 4305656 (E.D. Ark. 2022), leaves us shaking our heads. The court denied the…
Source: lexology.com
FDA issues final guidance for importing drugs prior to anticipated approval | Hogan Lovells
Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding requests for...
National Drug Code Federal Food Cosmetic Act Pre Launch Activities Importation Request Border Protection Prior Approval Supplement
Source: jdsupra.com
FDA Releases Guidance On CMC Changes To An Approved Application Certain Biological Products
FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products By Mark Durivage, Quality Systems Compliance LLC On June 21, 2021, the FDA released a new guidance, Chemistry, Manufacturing, and Controls Changes (CMCs) to an Approved Application: Certain Biological Products, to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) ...
Mark Durivage Public Health Service Act Quality Systems Compliance Controls Changes Approved Application Certain Biological Products
Source: meddeviceonline.com