A California recently indicated he would stay a putative class action raising allegations about labeling of “evaporated cane juice” pendin
Continue Reading Proposed Class Action Stayed Pending FDA Guidance
guidance
FDA Issues Further Nanotechnology Guidance
By Sean Wajert on
Late last month, the U.S. Food and Drug Administration issued one draft and three final guidance documents related to the use of nanotechnology in reg…
Continue Reading FDA Issues Further Nanotechnology Guidance
Federal Court Dismisses Cane Juice Class Under Primary Jurisdiction Doctrine
By Sean Wajert on
A California federal court took a second look and decided to dismiss a proposed class action related to the ingredient “evaporated cane juice&rd…
Continue Reading Federal Court Dismisses Cane Juice Class Under Primary Jurisdiction Doctrine
FDA Issues Draft Guidance on Social Media
By Sean Wajert on
Posted in Articles, Drug and Device
The U.S. Food and Drug Administration recently took a small step towards providing industry with the long-awaited guidance on how pharmaceutical maker…
Continue Reading FDA Issues Draft Guidance on Social Media
CHPA Comments on Draft FDA Guidance on Nanotechnology
By Sean Wajert on
Last week, the Consumer Healthcare Products Association (CHPA) submitted comments on the FDA’s draft guidance on nanotechnology, “Consideri…
Continue Reading CHPA Comments on Draft FDA Guidance on Nanotechnology
FDA Releases Draft Guidance on Nanotechnology
By Sean Wajert on
The U.S. Food and Drug Administration last week released draft guidance designed to move the process forward of providing its regulated industries wit…
Continue Reading FDA Releases Draft Guidance on Nanotechnology
PhRMA Issues New Principles on Clinical Trials
By Sean Wajert on
Posted in Articles, Drug and Device
Readers of MassTortDefense know how the conduct and results of clinical trials can reach out and affect later product liability litigation: plaintiffs…
Continue Reading PhRMA Issues New Principles on Clinical Trials
Device Group Comments on FDA Draft Guidance on Risk Information
By Sean Wajert on
Posted in Articles, Drug and Device
Readers of MassTortDefense know how FDA regulatory treatment of advertising and promotion can impact product liability litigation involving drugs and …
Continue Reading Device Group Comments on FDA Draft Guidance on Risk Information
FDA Issues New Draft Guidance on Presenting Risk Information
By Sean Wajert on
Posted in Articles, Drug and Device
The FDA recently issued a new draft Guidance for Industry titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.
Continue Reading FDA Issues New Draft Guidance on Presenting Risk Information
FDA Issues Guidance On Distribution Of Medical And Scientific Articles Regarding Off-Label Usage
By Sean Wajert on
Posted in Articles, Drug and Device
The FDA has finalized guidelines for how manufacturers can distribute information to doctors about unapproved uses for drugs or medical devices. The &…
Continue Reading FDA Issues Guidance On Distribution Of Medical And Scientific Articles Regarding Off-Label Usage