FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Releases Labeling Changes Approved in November

[ Price : $8.95]

FDA releases labeling changes for 27 drugs approved in November, including changes to Contraindication information for three drugs...

Congressmen Want Cyber Breach Answers

[ Price : $8.95]

Leaders of the House Energy and Commerce Committee ask FDA commissioner Margaret Hamburg for details about an October cyber securi...

Baxter BLA for New Factor VIII Submitted

[ Price : $8.95]

Baxter International files a BLA for OBI-1, a recombinant antihemophilic porcine sequence factor VIII for treating patients with a...

CGMP Violations Found at Ameriderm

[ Price : $8.95]

FDAs New Jersey District Office warns Ameriderm Laboratories about CGMP violations in its production of drug products.

Multiple Violations Found at Sharplight Technologies

[ Price : $8.95]

FDA warns Sharplight Technologies about regulatory violations in its manufacturing of powered surgical laser instruments.

FDA Panel Backs Takeda BLA for Crohns, Ulcerative Colitis

[ Price : $8.95]

A joint FDA advisory committee votes to recommend approval for a Takeda Pharmaceutical BLA for vedolizumab and its use in treating...

FDA Inspection Finds Violations at Jubilant HollisterStier

[ Price : $8.95]

FDAs Seattle District Office warns Jubilant HollisterStier about CGMP violations in its manufacturing of finished pharmaceuticals....

PhRMA Wants FDAMA Section 114 Guidance

[ Price : $8.95]

PhRMA calls on FDA to issue guidance on how drug companies can disseminate healthcare economic data under FDAMA Section 114 withou...

AbbVie Study Shows 96% Response with Genotype 1 Hepatitis C

[ Price : $8.95]

AbbVie reports positive data from its SAPPHIRE-II study of a three direct-acting-antiviral regimen plus ribavirin in patients with...

FDA OKs New Dose for Zogenix Migraine Treatment

[ Price : $8.95]

FDA approves a Zogenix supplemental NDA for a 4 mg dose of Sumavel DosePro Needle-free Delivery System.