Go to Wolters Kluwer VitalLaw.comGo to Wolters Kluwer VitalLaw.com
VitalLaw®
  • Find answers to your questions
  • Log in to access your subscriptions
In depth. On point.
In depth. On point.
  • Home
  • Legal Directory
  • Home
  • Legal Directory
In depth. On point.
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations
    • FALSE CLAIMS ACT—N.D. Ind.: Falsity and Provider’s knowledge of falsity in CPT code use were issues for trial
    • ADMINISTRATION OF FDC ACT—NOTICES: Fee Rate for Using a Priority Review Voucher in Fiscal Year 2025
    • ADVERTISING (FOOD, DRUG & MEDICAL DEVICES)—N.D. Ill.: Alleged unfair practice claim from presence of benzene in Differin acne products survives dismissal
    • CLINICAL RESEARCH—FDA GUIDANCE NOTICES: Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability
    • DRUGS AND BIOLOGICS—NOTICES: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability
    • ELECTRONIC HEALTH RECORDS—S.D.N.Y.: Privacy violation claim alleging unauthorized disclosure of private health information may proceed
    • EXPERT INSIGHTS—Massachusetts Board Of Pharmacy To Take A Big Step: Licensing Nonresident Pharmacies
    • FRAUD AND ABUSE—E.D.N.Y.: Exclusion of physician from federal health care programs was supported by substantial evidence
    • GENERAL HEALTH CARE NEWS: KFF looks at post-Medicaid ‘unwinding’ enrollment
    • GENERAL HEALTH CARE NEWS—D.S.C.: Products liability claims against maker of Peridox Disinfectant Cleaner may go forward
    • HEALTH CARE EMPLOYMENT ISSUES—N.D. Ill.: Court holds Illinois right of conscience act bars COVID-19 vaccine religious exemption cases
    • LAW FIRM NEWS—Noteworthy developments in the legal community
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations

    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability, (Sep 20, 2024)

    By WK Editorial Staff

    The FDA is announcing the availability of a draft guidance for industry entitled “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice.”

    FDA is publishing this draft guidance as part of ...

    By WK Editorial Staff

    The FDA is announcing the availability of a draft guidance for industry entitled “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice.”

    FDA is publishing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act to issue guidance about the use of RWE in regulatory decision-making. This draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that can integrate research into routine clinical practice. (Notice, 89 Fed. Reg. 76482 (Sept. 18, 2024)).

    Dates. Submit either electronic or written comments on the draft guidance by December 17, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    FederalRegisterIssuances: FDAGuidanceNotices ClinicalNews DrugBiologicNews

    © 2026 CCH Incorporated and its affiliates and licensors. All rights reserved.

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use