fda

Documents about fda

• FDA Regulation of Health and Fitness Equipment#485742Harvard DASH
• Priority without progress: the FDA's neglected tropical disease voucher program after 18 years#173814Scholarly Commons at Boston University School of Law
• Synthetic strategies and therapeutic insights into FDA-approved indole-containing drugs#4695Europe PMC
• Repositioning FDA-approved drugs to identify potential mycobacterial FadD23 inhibitors.#309646ResearchSpace
• FDA and the Challenge of Alternative Medicine: Realistic Assessments and Regulatory Flexibility#485748Harvard DASH
• UC Comments on the FDA-NIH Resource on Terminology for Clinical Research#629294eScholarship
• UC Comments on FDA Docket No. FDA-2019-N-2175 for “Institutional Review Boards; Cooperative Research.” (September 28, 2022)#629321eScholarship
• 1. Activities at FDA#69841J-STAGE (Japan)
• Better Fighting Through Chemistry? The Role of FDA Regulation in Crafting the Warrior of the Future#485763Harvard DASH
• UC Comments on FDA Final Order regarding Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Acton [FDA-2008-N-0567-0055]#629352eScholarship
• Privacy policies for FDA-authorized or FDA-recognized digital therapeutics impose high digital health literacy demands: a cross-sectional analysis.#645379NCBI PubMed Central
• UC Comments in Response to FDA's Proposed Guidance for Sponsors, Investigators,and Institutional Review Boards on Key Information and Facilitating Understanding in Informed Consent (Docket Number: FDA-2022-D-2997)#629288eScholarship
• UC Request to FDA to Extend Comment Period for Docket No. FDA-2021-N-0286 for “Protection of Human Subjects and Institutional Review Boards” (September 28, 2022)#629313eScholarship
• FDA-approved antisense oligonucleotide therapies for duchenne muscular dystrophy: current status and future outlook#314819Europe PMC
• UC Comments on FDA Guidance Document: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices (FDA-2021-D-0368)#624288eScholarship
• FDA Regulation of Physicians' Professional Speech.#630821NCBI PubMed Central
• FDA, Politics, and Public Health#168665Digital Commons @ American University Washington College of Law
• The FDA Ought to Change Plan B’s Label#75549PhilArchive
• FDA-approved therapies for chronic GVHD.#143324NCBI PubMed Central
• Adaptive Optics Retinal Imaging#303635ClinicalTrials.gov
• Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review#288237HAL (France)
• E-Cigarettes and the Multiple Responsibilities of the FDA#771770PhilArchive
• Assessing the effectiveness of FDA regulation of energy drinks#274839KNUSTSpace
• The History of Organic Food Regulation#485752Harvard DASH
• Human Perception on Medical Extended Reality Devices#806296ClinicalTrials.gov
• The Pressing Need of FDA Regulation of Tattoo Ink#1148942Villanova University Charles Widger School of Law Digital Repository
• UC Comments on FDA's Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability (Docket No. FDA-2021-D-1214, December 9, 2021)#629324eScholarship
• FDA Evidentiary Standards and the need to Attend to Stakeholders’ Values#74625PhilArchive
• The Patent Option#1019597Scholarship@Vanderbilt Law
• The Paradox of Legal Equivalents and Scientific Equivalence: Reconciling Patent Law's Doctrine of Equivalents with the FDA's Bioequivalence Requirement#306051Scholarly Commons at Boston University School of Law
• 21 U.S.C. § 387a — FDA authority over tobacco products#577205US Code (LII)
• UC Comments on Docket No. FDA-2021-N-0286 for “Protection of Human Subjects and Institutional Review Boards” (September 28, 2022)#629312eScholarship
• UC Request for Extension to Comment Period: Docket No. FDA-2019-N-2175 for “Institutional Review Boards; Cooperative Research.” (September 28, 2022)#629323eScholarship
• NIH-FDA Nutrition Regulatory Science Workshop: advancing research and policy.#222954NCBI PubMed Central
• Statement on the proposed FDA regulation limiting the sale of vitamin A#296449Zenodo (CERN)
• Consumerism, Conformity, and Uncritical Thinking in America#485741Harvard DASH
• Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study#885379ClinicalTrials.gov
• [Trial of device that is not approved or cleared by the U.S. FDA]#800693ClinicalTrials.gov
• [Trial of device that is not approved or cleared by the U.S. FDA]#801064ClinicalTrials.gov
• [Trial of device that is not approved or cleared by the U.S. FDA]#801842ClinicalTrials.gov
• [Trial of device that is not approved or cleared by the U.S. FDA]#801937ClinicalTrials.gov
• [Trial of device that is not approved or cleared by the U.S. FDA]#801947ClinicalTrials.gov
• [Trial of device that is not approved or cleared by the U.S. FDA]#802413ClinicalTrials.gov
• [Trial of device that is not approved or cleared by the U.S. FDA]#803008ClinicalTrials.gov
• The Supreme Court Sides with the FDA on the Abortion Pill – For Now#1241607Scholarly Commons at Boston University School of Law
• 21 U.S.C. § 384f — Strengthening FDA and CBP coordination and capacity#577238US Code (LII)
• UC Comments on Certificates of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff: Availability (FDA-2019-D-3592)#629368eScholarship
• Drug-associated insomnia: A pharmacovigilance study based on FDA adverse event reporting system.#122999NCBI PubMed Central
• Rebalancing the narrative on MHT the menopause momentum continues following FDA unboxing !#294974ScholarBank@NUS
• The History of Aspartame#485740Harvard DASH

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