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    • ELECTRONIC HEALTH RECORDS—M.D. Tenn.: Case against health system over tracking technologies remanded to state court
    • ADMINISTRATION OF FDC ACT—NOTICES: Issuance of priority review voucher for Atebrioz, rare pediatric disease product
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    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Suspension of DEA COR legal basis for CMS revocation, preclusion listing
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    • DRUGS AND BIOLOGICS—NOTICES: Determination that Pepcid RPD (tFamotidine) orally disintegrating tablets were not withdrawn from sale for reasons of safety, effectiveness
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    • DRUGS AND BIOLOGICS—NOTICES: Individualized human genome editing products draft guidance recommends considerations for BLA submission, postapproval management
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    • FALSE CLAIMS ACT—SETTLEMENT AGREEMENTS: Dialysis Centers agree to pay $2M to settle fraudulent PRF claims from COVID-19 era
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    • HEALTH INFORMATION TECHNOLOGY—FINAL RULES: Final Rule cuts health IT certification requirements and advances FHIR-focused framework
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    • MEDICAL DEVICES—NOTICES: Electronic submission template for investigational device exemption (IDE) applications draft guidance provides recommendations
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    • WHITE HOUSE NEWS—Cyber Pilot Program for Rural Hospitals Launched by White House
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    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: Individualized human genome editing products draft guidance recommends considerations for BLA submission, postapproval management, (Oct 29, 2026)

    By WK Editorial Staff

    The guidance also addresses related topics, including potency and safety evaluation of product variants, manufacturing process validation, labeling and indication statements, and drug naming and identification.

    The FDA issued a draft guidance titled & ...

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