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Medical Devices

LimFlow Gains Approval for Leg Ischemia

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

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Medical Devices

45 Device Alerts Issued in 2022: FDA

FDA issues its first Postmarket Device Safety-Related Communications report to Congress that details 45 safety-related communications issued in 2022.

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Human Drugs

Justice Petitions Supreme Court Over Mifeprex

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

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...

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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...

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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.

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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...

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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...

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Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Peptide Drug Products.

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CMC Readiness Pilot Program

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