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Human Drugs

FDA in New AMP Heart Failure Program

FDA joins with the NIH and other organizations in a new Accelerating Medicines Partnership program on heart failure.

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Human Drugs

Amylyx Lou Gehrigs Disease Drug Approved

FDA approves Amylyxs amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate and taurursodiol).

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Human Drugs

Senate OKs Bill Ending Animal Testing Mandates

The Senate unanimously approves legislation to end an FDA mandate for animal testing of experimental drugs before they can be used in human clinical t...

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Medical Devices

Medtronics Hemostasis Agent Cleared for Upper GI

FDA clears a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system.

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Human Drugs

Mfr. Deficiencies Hamper 1st Cycle ANDA Reviews

Writing in a medical journal, CDER researchers say manufacturing-related deficiencies contribute significantly to a low first-review-cycle approval ra...

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Medical Devices

Medical Device Data Systems Guidance

FDA publishes a revised guidance on medical device data systems to conform with the 21st Century Cures Act.

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Human Drugs

Comments on COA Guidance

Four stakeholders suggest ways FDA could improve a draft guidance on fit-for-use clinical outcome assessments.

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Animal Drugs

Generic Adspec Approved for Bovine Pneumonia

FDA approves Bimeda Animal Healths SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Healths Adspec.

Medical Devices

Radiology Display Device Submission Guidance

FDA publishes a guidance on preparing 510(k) submissions for display devices intended for diagnostic radiology.

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Federal Register

Animal Drug Application Actions Posted

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...