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FDA Denies 2 Covid-19 Vaccine Petitions

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

Takeaways from Clinical Trial Enforcement Panel

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Four Morrison Foerster attorneys list several FDA-focused takeaways from a recent panel presentation on compliance and cybersecuri...

2 CBER Standard Operating Policies, Procedures

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

NEST Unique Device Identifier Playbook

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

GSK Reports Favorable Data from TB Therapy Trial

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

GEs DaTscan Expanded Dementia Use OKd

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

Lupin Hit with Another FDA-483

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

Pass PASTEUR Act Before Congress Ends: 165 Groups

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

Warning Letter Top 10 GMP Deficiencies

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

Mendoza Debarred for 5 Years Over Drug Imports

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Federal Register notice: FDA issues an order debarring David Elias Mendoza for five years from importing or offering for import an...