FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CGMP Violations at TJA Health

[ Price : $8.95]

FDA warns Joliet, IL-based TJA Health about CGMP violations in its manufacturing of finished drugs.

Quality CDMO Marketing Unapproved Drugs: FDA

[ Price : $8.95]

FDA warns Fort Worth, TX-based Quality CDMO that it is marketing five unapproved new drugs.

Consider Phased DSCSA Enforcement: PhRMA

[ Price : $8.95]

PhRMA asks FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act because many drug company trading par...

Kisqali Expanded Approval for Early Breast Cancer

[ Price : $8.95]

FDA approves an expanded use for Novartis Kisqali (ribociclib) combination use with an aromatase inhibitor for the adjuvant treat...

FDA Lifts Partial Clinical Hold on Alzheimers Drug

[ Price : $8.95]

FDA lifts a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule t...

CGMP Violations at Italian Drug Plan

[ Price : $8.95]

In an untitled letter, FDA says Milan, Italy-based Industria Farmaceutica is manufacturing drugs with CGMP violations.

FDA Extends Treosulfan NDA Review by 3 Months

[ Price : $8.95]

Medexus Pharmaceuticals says FDA has extended the review of its Medac licensors resubmitted NDA for treosulfan and its use in allo...

SSM St. Clare Health Gets FDA-483

[ Price : $8.95]

FDA issues SSM St. Clare Health Center a 10-observation Form FDA-483 for GMP deficiencies found during an inspection at an outsour...

Guide on Oncology Multiregional Clinical Trials

[ Price : $8.95]

FDA posts a draft guidance entitled Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Developme...

3 De Novo Device Classifications

[ Price : $8.95]

Federal Register notices: FDA classifies three devices into Class 2 based on de novo classification requests Saladax Biomedicals ...