FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Petition Seeks Medifil Sodium Chloride RLD Designation

[ Price : $8.95]

A citizen petition requests that FDA designate Medefils sodium chloride injection, USP, 0.9% in prefilled plastic syringes as a se...

Guidance on Drugs for Acute Bacterial Sinusitis

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Acute Bacterial Sinusitis: Developing Drugs for Treatment.

FDA Cracks Down on Unapproved B&L, Akorn Drugs

[ Price : $8.95]

FDA issues Warning Letters to Bausch & Lomb and Akorn for manufacturing and shipping unapproved pilocarpine hydrochloride ophthalm...

Mutual Petitions FDA to Block Generic Colcrys

[ Price : $8.95]

Mutual Pharmaceutical Co. petitions FDA seeking to prevent ANDAs referencing Colcrys (colchicine) that may carve out its indicatio...

Inspection Finds QS Problems at Hospira Costa Rica

[ Price : $8.95]

FDA warns Hospira Costa Rica about Quality System Regulation violations in its manufacturing of infusion pumps and intravascular a...

Sanofi, Mass General Partner on Tumor Therapy Development

[ Price : $8.95]

Sanofi announces a two-year agreement with Massachusetts General Hospital to advance translational medicine research and to develo...

History of Pharmacy Compounding: Its Values and Risks

[ Price : $8.95]

FDA Webview editor Jim Dickinson reviews the frustrating history of compounding pharmacys relations with FDA in light of the curre...

FDA, Stryker Warn on Surgical Vacuum Injury, Death

[ Price : $8.95]

FDA and Stryker warn healthcare providers about potential serious injuries to surgical patients due to misuse of the companys high...

Former Commish Kessler Not Testifying in Risperdal Case

[ Price : $8.95]

Johnson & Johnson settles five Risperdal cases which prevents former FDA commissioner David Kessler from testifying about its alle...

FDA Prosecutorial Discretion Key in Preemption Cases: Lawyer

[ Price : $8.95]

Reed Smith lawyer Jim Beck says medical product makers arguing preemption should remember to cite FDA prosecutorial discretion as ...