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How GPCR-targeting therapies are advancing the fight against inflammatory disease

Drug Target Review

In March 2025, Domain Therapeutics disclosed DT-9046 as an oral drug candidate for inflammatory diseases, including AD, IBD and arthritis, as well as pain. DT-9046 is currently progressing through pre-IND studies, supported by a robust data package, including head-to-head benchmarks and strong patent protection.

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FDA Issues Proposed Order to Facilitate Minor Changes to Solid Oral Dosage Forms to OTC Monograph Drugs, but Such Changes May Come at a Price

FDA Law Blog: Biosimilars

The requirement for the single-unit or unit-dose containers is not a substitute for special packaging, i.e., child resistant packaging required for certain products under the Poison Prevention Packaging Act and implementing regulations. See 16 C.F.R.

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ACI’s Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition

FDA Law Blog: Biosimilars

The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California.

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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

FDA Law Blog: Biosimilars

Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. By Sarah Wicks & Michelle L.

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Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

FDA Law Blog: Biosimilars

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

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CMS Proposals Would Raise the Bar on Bona Fide Service Fees for Average Sales Price

FDA Law Blog: Biosimilars

The proposed rule will be published in the Federal Register of July 16, and comments may be submitted here until September 12, 2025. CMS proposes to add a definition of “bundled arrangement” to the existing ASP regulations at 42 C.F.R.

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

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