FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accepts NDA for Espero Pharmas GoNitro

[ Price : $8.95]

FDA accepts for review an Espero Pharmaceuticals NDA for GoNitro (nitroglycerin powder) for sublingual use for acute relief of an ...

Lawyers Suggest Future FDA Enforcement Trends

[ Price : $8.95]

Attorneys Raymond Bonner and William McConagha predict a busy FDA enforcement schedule in the next three to five years, especially...

Patient, Physician Groups Endorse Califf as Next FDA Head

[ Price : $8.95]

In the face of stiffening opposition from Public Citizen, among others, a letter addressed to Senate leaders by 50 patient and hea...

Pull Califf Nomination: Public Citizen

[ Price : $8.95]

Public Citizen Health Research Group director Michael Carome says there are additional reasons why President Obama should withdraw...

Pfizer Wants Purdue OxyContin Petition Denied

[ Price : $8.95]

Pfizer calls on FDA to deny a recent Purdue Pharma petition asking that Pfizer be required to reference a Purdue drug in its appli...

Omthera Cites Amarin Case for Epanova Exclusivity

[ Price : $8.95]

Omthera says a federal court decision in the Amarin case supports its argument that its Epanova is entitled to five-year new chemi...

FDA Clears Reflexion Health Vera Physical Therapy Tool

[ Price : $8.95]

FDA clears a Reflexion Health 510(k) for its motion-tracking physical therapy tool, Vera.

Production/Process Controls Top QS Citation in Device Inspections

[ Price : $8.95]

CDRH says Production and Process Controls and Corrective and Preventive Actions continue to be the most frequently cited Quality S...

FDA Sends Info on Rx Drug Labeling to OMB

[ Price : $8.95]

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

FDA Grants Progesterone Gel Guidance Request

[ Price : $8.95]

FDA grants and denies portions of a Watson petition on bioequivalence guidance and studies for progesterone gel.