FDA Related News

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...

Human Drugs

GEs DaTscan Expanded Dementia Use OKd

FDA approves an expanded use for GE Healthcares DaTscan (ioflupane I 123 injection) for use in patients with suspected dementia with Lewy Bodies.

Human Drugs

Lupin Hit with Another FDA-483

FDA issues a five-item Form FDA-483 after conducting a pre-approval inspection of Lupins Nagpur, India Unit-2 injectable manufacturing facility 10-17-...

Human Drugs

Pass PASTEUR Act Before Congress Ends: 165 Groups

Some 165 healthcare-related organizations urge Congress to pass the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act before the ...

Human Drugs

Warning Letter Top 10 GMP Deficiencies

ECA Academy lists the top 10 GMP observations from 42 Warning Letters issued in FY 2022.

Federal Register

Mendoza Debarred for 5 Years Over Drug Imports

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