FDA Related News

Medical Devices

Smiths Recalls Medfusion 4000 Syringe Pumps

Smiths Medical recalls its Medfusion 4000 Syringe Pumps due to malfunctioning alarms and potential therapy interruption.

Medical Devices

Chembio Expects HIV/Syphilis Approval in 2 Months

Chembio Diagnostics says it expects FDA approval in two months on its PMA for the DPP HIV-Syphilis System.

Medical Devices

Stakeholders Want CDS Guidance Clarified

Several stakeholders call on FDA to further clarify and explain its revised draft guidance on clinical decision support software.

Biologics

FDA Accepts Immunomedics Resubmitted BLA

FDA accepts for review an Immunomedics resubmitted BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients...

Human Drugs

Patient-Focused Drug Development Guidance Comments

Stakeholders suggest areas where more clarification is needed in an FDA draft guidance on how to identify what is important to patients as part of pat...

Human Drugs

Rare Disease Therapeutic Modalities Analyzed

Journal authors, including FDAers, analyze therapeutic modalities that could be used in developing new orphan drugs.

Human Drugs

Comments on Postmarketing Studies Draft Guidance

Stakeholders comment on an FDA draft guidance on postmarketing studies and clinical trials.

Human Drugs

Correvio Pharma NDA Again Rejected Over Safety Concerns

FDA again issues Correvio Pharma a complete response letter on its NDA for Brinavess (vernakalant IV), an anti-arrhythmic drug for converting atrial f...

Human Drugs

Eisai Insomnia Drug Approved by FDA

FDA approves an Eisai NDA for Dayvigo (lemborexant) 5 mg and 10 mg for treating adult patients with insomnia.

FDA Draft Bridging Guidance Out

FDA publishes a draft guidance recommending how to approach bridging in NDAs or BLAs for some drug-device and biologic-device combination products.