FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Illinois Court Has Different Take on Preemption: Lawyers

[ Price : $8.95]

A medical device product liability lawsuit overcomes a federal preemption defense by relying on a controversial Seventh Circuit Co...

Caronia Decision Dissected in Harvard Law Review

[ Price : $8.95]

This months Harvard Law Review takes a look at the year-old Caronia court decision and finds that while it is defensible as a matt...

Ariad Gets FDA OK to Return Iclusig to Market

[ Price : $8.95]

FDA approves Ariad Pharmaceuticals plan to return its leukemia drug Iclusig (ponatinib) to the market.

FDA OKs AXIOS Stent for Pancreas Pseudocysts

[ Price : $8.95]

FDA approves an Xlumena de novo petition for the AXIOS Stent and Delivery System for treating pseudocysts that form in the pancrea...

Attorneys Advise Firms to Find Ways to Argue Preemption

[ Price : $8.95]

Attorneys writing the Drug and Device Law blog urge drug and medical device companies to argue federal preemption of off-label saf...

Sandoz Opens Follow-on Humira Phase 3 Trial

[ Price : $8.95]

Sandoz initiates a Phase 3 study of its biosimilar version of AbbVies Humira.

Info on Device Communications Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on testing commun...

Workshop on Endpoints on Intraocular Lenses

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 3/28/14: FDA/American Academy of Ophthalmology (AAO) Workshop on Developing N...

FDA Modernizes Citizen Petition Regs to Include E-Submissions

[ Price : $8.95]

Federal Register Final rule: FDA modernizes its administrative regulations on submitting citizen petitions to explicitly provide f...

FDA Grants, Denies Teva ProAir Petition

[ Price : $8.95]

FDA says it would determine on a case-by-case basis whether an ANDA or 505(b)(2) application citing Tevas ProAir as the reference ...