FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Caregivers Missing Safety Signals on Celgenes Idhifa

[ Price : $8.95]

FDA warns that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being identified in pa...

FDA Inspection Agreements with 20 EMA Members

[ Price : $8.95]

The European Medicines Agency says FDA has confirmed the capability of five more member states to conduct drug inspections.

Suggestions for FDA Adaptive Design Draft Guidance

[ Price : $8.95]

Stakeholders praise an FDA draft guidance on adaptive designs for drug and biologic trials and offer some recommendations for impr...

FDA Efforts on Drug Shortages Told at Policy Conference

[ Price : $8.95]

Several CDER experts report to a drug shortage conference on agency efforts to date to take a fresh look at the drivers of drug sh...

Joint Panels to Review Uloric Cardiovascular Safety

[ Price : $8.95]

Federal Register notice: FDA announces a 1/11/2019 joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Mana...

FDA Issues 63 Product-Specific Guidances for Generics

[ Price : $8.95]

FDA issues 63 new and revised product-specific guidances to promote development of generic drugs.

Objectionable Study Conditions at Corona Doctors Medical

[ Price : $8.95]

FDA warns Corona Doctors Medical Clinics about objectionable conditions in its conduct of a clinical investigation.

Ortho Gains Expanded Use for HIV Combo Test

[ Price : $8.95]

FDA approves an Ortho Clinical Diagnostics expanded indication for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and...

gammaCore Nerve Stimilator Expanded for Headaches

[ Price : $8.95]

FDA clears an electroCore 510(k) for an expanded label for gammaCore vagus nerve stimulator therapy for adjunctive use for prevent...

CLIA Waiver Applications Update Guidance

[ Price : $8.95]

FDA issues a draft guidance to update Section V of a 2008 CLIA Waiver guidance.