FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

LimFlow Gains Approval for Leg Ischemia

[ Price : $8.95]

FDA approves a LimFlow PMA for its LimFlow System for treating patients with chronic limb-threatening ischemia who have no other s...

45 Device Alerts Issued in 2022: FDA

[ Price : $8.95]

FDA issues its first Postmarket Device Safety-Related Communications report to Congress that details 45 safety-related communicati...

Justice Petitions Supreme Court Over Mifeprex

[ Price : $8.95]

The Department of Justice petitions the U.S. Supreme Court asking it to reverse last months decision by the Fifth Circuit Court of...

Updated Covid-19 Vaccines Approved by FDA

[ Price : $8.95]

FDA gives the green light for updated Covid-19 vaccines manufactured by ModernaTX and Pfizer that are formulated to more closely t...

Tagrisso Phase 3 Data in Lung Cancer

[ Price : $8.95]

AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy in lung cancer patients ...

Pregnancy Safety Study Workshop Planned

[ Price : $8.95]

FDA and Duke-Margolis Center for Health Policy announce a 9/18-19 two-day public workshop to discuss pregnancy safety studies.

FDA Seeks Industry Help with Vaccine Panel

[ Price : $8.95]

Federal Register notice: FDA seeks participation by industry organizations in selecting nonvoting industry representatives to serv...

IRB Review Guide for Expanded Access

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Institutional Review Board (IRB) Review of Individual Patie...

Guide on Peptide Clin-Pharm Considerations

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Peptide Drug Produ...

CMC Readiness Pilot Program

[ Price : $8.95]

Federal Register notice: FDA announces an opportunity to participate in its Chemistry, Manufacturing, and Controls (CMC) Developme...