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Biologics

Orchards Leukodystrophy Gene Therapy OKd

FDA approves an Orchard Therapeutics BLA for Lenmeldy (atidarsagene autotemcel), a one-time, single-dose gene therapy indicated for treating children ...

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Human Drugs

Sleepnet Recalls Sleep Apnea Masks

Sleepnet recalls its CPAP and BIPAP sleep apnea masks with magnets due to potential interference with certain medical devices.

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Human Drugs

CDER Launches Inspections Web Page

FDA launches a new Web page to highlight how it uses inspections to help ensure drug safety and quality.

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Human Drugs

More Info on Quality Manufacturing Maturity

FDA provides additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturity Prototype Assessm...

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Human Drugs

Generic Drug Controlled Correspondence Guidance

FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.

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FDA General

FDA Paper on AI Targets 4 Focus Areas

FDA posts a cross-Center paper entitled Artificial Intelligence (AI) & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together that ident...

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Federal Register

Device Q-Submission Feedback Draft Guidance

Federal Register notice: FDA makes available a draft guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submis...

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Federal Register

Draft Guidance in Device Thermal Effects

Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating an...

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Federal Register

Medical Device Regs Technical Amendment

Federal Register notice: FDA amends certain medical device regulations to update a citation for information collection and conform the regulatory prov...

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Medical Devices

FDA Guidance on Device Thermal Effects

FDA publishes a draft guidance on the information that should be in medical device premarket submissions to support an evaluation of the devices therm...