FDA Related News

Biologics

Updated Covid-19 Vaccines Approved by FDA

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

Human Drugs

Tagrisso Phase 3 Data in Lung Cancer

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

Human Drugs

Pregnancy Safety Study Workshop Planned

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

Federal Register

FDA Seeks Industry Help with Vaccine Panel

Federal Register notice: FDA seeks participation by industry organizations in selecting nonvoting industry representatives to serve on the Vaccines an...

Federal Register

IRB Review Guide for Expanded Access

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

Federal Register

Guide on Peptide Clin-Pharm Considerations

Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Peptide Drug Products.

CMC Readiness Pilot Program

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

Medical Devices

S4 De Novo Authorization for esolution

FDA grants S4 Medical a de novo authorization to market its esolution esophageal deviation device.

Human Drugs

Novartis Recalls Sandimmune Lot

Novartis recalls one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation observed in some bottle...

Medical Devices

FDA Updates Alert on Halyard N95 Masks

FDA provides further clarification about a safety alert issued earlier this year that recommended against the use of certain surgical N95 respirators ...