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OMB Approves 18 Information Collections

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Federal Register notice: FDA posts a list of 18 information collections that have been approved by OMB.

MCM Annual Report Achievements

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FDA releases the 2022 medical countermeasures annual report covering 14 key agency activities to support the development of and ac...

FDA Keeps Concert Drugs Breakthrough Status

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FDA says Concert Pharmaceuticals deuruxolitinib can retain its breakthrough therapy designation to treat alopecia areata.

Galera Priority Review for Oral Mucositis Drug

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FDA accepts for priority review a Galera Therapeutics NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis ...

Court Action on 3 Claims Explained

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The latest Foley Hoag product liability update covers a Massachusetts federal courts ruling on three aspects of a case involving C...

Pediatric Drug Extrapolation in U.S. Analyzed

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Researchers say the use of pediatric extrapolation in a six-year period increased the rate of new and expanded pediatric indicatio...

Bryan Concerns About Gene Therapy Accelerated OKs

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The outgoing director of the CBER Office of Tissues and Advanced Therapies, Wilson Bryan, expresses concern about the length of co...

Sunrise At-Home Sleep Apnea Test Cleared

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FDA clears a 510(k) submitted by Belgium-based Sunrise for its second generation at-home sleep apnea test that uses artificial int...

FDA Facing Backlog of ODE Determinations: Attorneys

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Two Morgan Lewis attorneys explore decisions facing FDA in light of an 11th Circuit Court of Appeals ruling on orphan drug exclusi...

AdvaMed Comments on Inspection Delay Guidance

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AdvaMed suggests changes to an FDA draft guidance on delaying, denying, limiting, or refusing a drug or device inspection.