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Skinny Label Safe Harbor Bills Introduced

[ Price : $8.95]

Lawmakers introduce bipartisan legislation in the House and Senate to provide a skinny label safe harbor for certain human and ani...

Tower Laboratories CGMP Violations

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FDA warns Montague, MI-based Tower Laboratories about CGMP violations in its manufacture of finished drugs.

Repeat CGMP Violations Seen in LiquidCapsule Inspection

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FDA warns Tampa, FL-based LiquidCapsule Manufacturing about repeated CGMP violations in its production of finished drugs.

Two Digital Health Guidances Published

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FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.

Formal Dispute Resolution Guidance

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FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of...

End-of-December Warning Letters

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FDA releases substantive Warning Letters in the last two weeks of December 2025.

FDA Releases Sun Pharmaceutical FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at the Sun Pharmaceutical Medicare sterile drug manufactu...

Industry Recommendations for BsUFA 4 Reauthorization

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A Hyman, Phelps & McNamara CMC regulatory expert lists the initial industry recommendations for improvements to be negotiated in t...

FDA to Review Inovio BLA to Treat RRP

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FDA accepts for review an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis.

Alumis Positive Data Reported for Psoriasis Drug

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Alumis says envudeucitinib delivered high levels of skin clearance in two pivotal Phase 3 trials in moderate-to-severe plaque psor...