FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Dakota Labs Consent Decree Approved

[ Price : $8.95]

FDA says a federal judge has accepted a consent decree closing Dakota Laboratories until CGMP violations are corrected.

Amgen Drug Fails Dyspnea Trial

[ Price : $8.95]

Amgen and Cytokinetics say their omecamtiv mecarbil failed to meet its endpoint in a trial with acute heart failure patients.

LipoScience Says New Cholesterol Marker Shows Promise

[ Price : $8.95]

Researchers say that measuring HDL-P may be a better marker for cardiovascular risk in patients receiving statin therapy.

FDA Clears Abyrxs Hemasorb Plus

[ Price : $8.95]

FDA clears an Abyrx 510(k) for its new resorbable hemostatic bone putty, Hemasorb Plus.

FDA Taps Plaisier as New Top Cop

[ Price : $8.95]

FDA selects former Central Region food and drug director Melinda Plaisier as the agencys new associate commissioner for regulatory...

MiMedx Challenges FDA Untitled Letter

[ Price : $8.95]

MiMedx says it disagrees with FDAs position that its amnion/chorion injectables are not eligible to be marketed under Section 361 ...

FDA Specifies DUNS as Drug Establishment Identifier

[ Price : $8.95]

FDA issues a guidance specifying the DUNS number as the unique facility identifier for drug establishments as required by FDASIA.

CGMP Violations Found at Spains Jabones Pardo

[ Price : $8.95]

FDA warns Spains Jabones Pardo about significant CGMP violations in manufacturing OTC drugs.

Stewart Pharma Warned About Compounding, CGMP Violations

[ Price : $8.95]

FDA warns Stewart Pharmaceuticals about drug compounding and CGMP violations.

FDA OKs New Vial Size for Hizentra

[ Price : $8.95]

FDA approves a CSL Behring supplemental BLA for a 10 g (50 mL) vial size for Hizentra (immune globulin subcutaneous - human).