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FDA General

FDA Planning White Oak Return Under Hybrid Approach

FDA commissioner Robert Califf and Oncology Center of Excellence director Richard Pazdur endorse a return of FDA employees to the White Oak, MD headqu...

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Medical Devices

Class 1 Recall on Omnipod Insulin Delivery System

An Insulet recall of its Omnipod DASH Insulin Management System receives a Class 1 recall classification by FDA.

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Federal Register

More Draft ANDA Bioequivalence Guides Available

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for use by ANDA sponsors.

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FDA General

FDA Cybersecurity Modernization Action Plan

Two FDA information technology executives describe the agencys new cybersecurity modernization action plan.

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Federal Register

FDA Preliminary Assessment on OTC Naloxone

Federal Register notice: FDA announces its preliminary assessment that certain types of naloxone hydrochloride drug products may be approvable as safe...

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Human Drugs

Put Aduhelm Approval on Hold: Researchers

Academic medical center researchers worldwide call on FDA to pause its approval of Biogens Aduhelm to treat Alzheimers disease while it investigates t...

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Human Drugs

CA Appeals Court Upholds Federal Preemption

Attorney Steven Boranian praises a California Court of Appeal decision invoking federal preemption in a failure-to-warn case involving the heart drug ...

Biologics

FDA Denies 2 Covid-19 Vaccine Petitions

FDA denies two Informed Consent Action Network petitions seeking agency action to modify emergency use authorizations for Covid-19 vaccines.

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Takeaways from Clinical Trial Enforcement Panel

Four Morrison Foerster attorneys list several FDA-focused takeaways from a recent panel presentation on compliance and cybersecurity challenges in cli...

Human Drugs

2 CBER Standard Operating Policies, Procedures

CBER issues two new Standard Operating Policies and Procedures covering BLAs, NDAs and their supplements and product licenses.