FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Info Collection on Device Tracking

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Device Tracking 21 CFR Pa...

FDA Reviewers Support Biogens Aducanumab

[ Price : $8.95]

FDA medical reviewers give a generally positive assessment of Biogens aducanumab that is indicated to delay clinical decline in pa...

STAQ Pharma Inspection FDA-483 Released

[ Price : $8.95]

FDA releases an FDA-483 with five observations from an inspection at STAQ Pharma.

GDUFA 3 Looks at Approving ANDAs Earlier

[ Price : $8.95]

FDA and the generic drug industry each offer proposals to advance quicker ANDA approvals.

Payments to Docs Correlate with ICD Choices: Study

[ Price : $8.95]

Researchers say there is a correlation between medical device company payments to doctors and the selection of defibrillator devic...

BMS Psoriasis Drug Posts Favorable Trial Results

[ Price : $8.95]

Bristol Myers Squibb announces positive results from POETYK PSO-1, a pivotal Phase 3 trial evaluating deucravacitinib, a novel, or...

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that include Cosmax USA and Immusist LLC.

De Novo Authorization for Glycemic Controller

[ Price : $8.95]

FDA authorizes the de novo marketing of Tandem Diabetes Cares Control-IQ Technology, an interoperable automated glycemic controlle...

Irradiation Regulation Repeal to Help OTC Drugs

[ Price : $8.95]

Federal Register notice: FDA issues a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug pro...

Boston Scientific Disposable Duodenoscope Cleared

[ Price : $8.95]

FDA clears a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope.