FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Mitsubishi Tanabe Resubmits NDA for Parkinsons Combo

[ Price : $8.95]

FDA accepts for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous ...

Zhejiang Huahai FDA-483 Released

[ Price : $8.95]

FDA releases the form FDA-483 with seven observations from a January inspection at Chinas Zhejiang Huahai Pharmaceuticals.

Multiple Issues at Germanys DRG Instruments

[ Price : $8.95]

FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not have FDA approval and are bei...

House Democrats Want Answers on HHS Staff Cuts

[ Price : $8.95]

Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secr...

FDA Publishes 2 Q-Submission Guidances

[ Price : $8.95]

FDA publishes two guidances relating to the CDRH/CBER Q-submission process.

GSK Plans for Antibiotic NDA in 2nd Half

[ Price : $8.95]

GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase...

26 FDA Orphan Drug Approvals in 2024

[ Price : $8.95]

CDERs Accelerating Rare Disease Cures online newsletter says there were 26 orphan drug approvals in 2024 and lists four approvals ...

RFK Jr. Attacks Corrupt Drug Firms and DTC Ads

[ Price : $8.95]

In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault against the pharmaceutical industry ...

Sen. Durbin Queries FDA on Drug Promo Staff Cuts

[ Price : $8.95]

Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDERs Office of Prescription Drug Promotion can adequately regul...

To Make FDA Great Again, Impeach RFK Jr.

[ Price : $8.95]

To make FDA great again, FDA Webview editor James G. Dickinson urges Congress to impeach HHS secretary RFK Jr. on four counts of m...