FDA Related News

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.

FDA General

FDA Cybersecurity Modernization Action Plan

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

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...

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...

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.

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.

Medical Devices

NEST Unique Device Identifier Playbook

The NEST Collaborating Community issues a draft playbook on using medical device unique device identifiers at the point of care.

Human Drugs

GSK Reports Favorable Data from TB Therapy Trial

GSK says a Phase 2a study showed that GSK3036656, an investigational antitubercular agent, was well tolerated and showed early bactericidal activity w...