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Federal Register

Drug Promotion Research on Mechanism of Action OKd

Federal Register notice: FDA announces that OMB has approved a new information collection entitled Targeted Mechanism of Action Presentations in Presc...

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Federal Register

FDA Debars Kempema for 5 Years

Federal Register notice: FDA issues an order debarring David J. Kempema for five years from importing or offering for import any drug into the U.S.

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Human Drugs

Harmonize Innovative Manufacturing Regulation: PhRMA

Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufacturing regulation wi...

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Medical Devices

AdvaMed Supports Breakthrough Device Guidance Updates

AdvaMed says it strongly supports FDA efforts to update a guidance on the breakthrough devices program.

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Medical Devices

VALID Could Hurt Home Sample Testing: Attorneys

Two Hyman, Phelps attorneys say the VALID bill contains what appears to be an inadvertent provision that could adversely affect telehealth testing of ...

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Human Drugs

Fresenius Kabi Gains Approval for Humira Biosimilar

FDA approves a Fresenius Kabi BLA for Idacio (adalimumab-aacf), a biosimilar product referencing AbbVies Humira (adalimumab).

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Human Drugs

Former NECC Ops Director Sentenced to 5 Months in Jail

A Massachusetts federal judge sentences the former New England Compounding Center operations director to five months in jail for conspiring to defraud...

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Medical Devices

TruLift Lateral Interbody Fusion Spacer Cleared

FDA clears a Life Spine 510(k) for the TruLift Lateral Expandable Spacer System and Lateral Plate System for use in lateral lumbar interbody fusions.

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Human Drugs

FDA Panel Thumbs Down on Heart Failure Drug

FDAs Cardiovascular and Renal Drugs Advisory Committee votes 8 to 3 against recommending approval of Cytokinetics omecamtiv mecarbil for treating hear...

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Federal Register

Endocrinologic/Metabolic Drugs Panel Renewed

Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.