FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

2 Vet4U Inspection Observations

[ Price : $8.95]

FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.

Redact CRLs for Unapproved Applications: Petition

[ Price : $8.95]

An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved appl...

Senate Democrats Target Trump Drug Pricing Deals

[ Price : $8.95]

Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administration to disclose the terms o...

FDA Denies Petition to Withdraw Approval of VenaSeal

[ Price : $8.95]

FDA denies a citizen petition seeking to withdraw approval of Covidiens VenaSeal vein-closure system, concluding the medical devic...

FDA Expands Approval of Sanofis Tzield to Younger Children

[ Price : $8.95]

FDA approves an expanded indication for Sanofis Tzield (teplizumab), allowing its use in children as young as one year old to dela...

4 Ways to Better Use CRISPR-Edited Therapies: Article

[ Price : $8.95]

Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to...

Reject Cipla NDA for Descovy Duplicate: Gilead

[ Price : $8.95]

Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.

Warning Letter to Firm Over Weight-loss/Diabetes Drugs

[ Price : $8.95]

FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys product...

FDA extends review for Sanofis subcutaneous Sarclisa

[ Price : $8.95]

FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in com...

UCSF Radiopharmaceutical Facility CGMP Issues

[ Price : $8.95]

FDA warns the University of California at San Francisco radiopharmaceutical facility about CGMP violations in its production of fi...