Inhalation

INH0824

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30 August 2024 Inhalation 21. Trends in the Prevalence of Chronic Obstructive Pulmonary Disease Among Adults Aged ≥ 18 Years — United States, Y Liu, S Carlson, K Watson, F Xu, K Greenlund, 2011-2021, CDC Weekly, November 17, 2023, 72(46);1250-1256. https://www.cdc.gov/ mmwr/volumes/72/wr/mm7246a1.htm. 22. CDC, Data, Statistics, and Surveillance. https://www.cdc.gov/asthma/asthmadata.htm#:~: t e x t=T h e % 2 0 c u r r e n t % 2 0 a s t h m a% 2 0 p r e v a lence%20a mong,signif ica ntly %20to%206.5% 25%20in%202021. 23. Referencing Approved Drug Products in ANDA Submissions, Guidance for Industry. https://www. fda.gov/media/102360/download. 24. Deconstructing Genus Medical Technologies, LLC, v. FDA: A Misunderstood Court Decision. https://www.ebgadvisors.com/insights/publications/ deconstructing-genus-medical-technologies- llc-v-fda- a-misunderstood-court-decision-continues-to-sow- confusion-and-may-prompt-congressional-action. 25. 21CFR 314.54(a): Part 314 - Applications for FDA Approval to Market a New Drug. https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?fr=314.54. 26. Draft Guidance on Albuterol Sulfate November 2023. November 2023. https://www.accessdata.fda. gov/drugsatfda_docs/psg/PSG_020503.pdf. 27. U.S. Supply Chain Vulnerabilities and Resil- ience. https://www.uscc.gov/sites/default/files/2022- 11/Chapter_2_Section_4--U.S._Supply_Chain_ Vulnerabilities_and_Resilience.pdf. 28. FTC Challenges More an 100 Patents as Improperly Listed in the FDA's Orange Book. https://www.ftc.gov/news-events/news/press- releases/2023/11/ftc-challenges-more-100-patents- improperly-listed-fdas-orange-book. Rik Lostritto is an independent consultant, based in Maitland, Florida, US, RTLostritto@gmail.com, LinkedIn: Richard Lostritto. 9. orat S, Meshram S. Review on Quality by Designing for Metered Dose Inhaler Product Devel- opment. Sch Acad J Pharm, 2015; 4(6):324-330. 10. Stein S, iel C. e History of erapeutic Aerosols: A Chronological Review. J Aerosol Med Pulm Drug Deliv, 2017 Feb; 30(1):20-41. 11. Pritchard J. e Climate is Changing for Metered-Dose Inhalers and Action is Needed. Drug Des Devel er, 2020; 14:3043-3055. 12. Kontny MJ, Destefano G, Jager P, McNamara D, Turi J, Van Campen L. Issues Surrounding MDI Formulation Development with Non-CFC Propel- lants. J Aerosol Med, 1991 Fall; 4(3):181-187. 13. 21CFR, Part 81.10(g), Termination of Pro- visional Listing Of Color Additives.(g). https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ cfrsearch.cfm?fr=81.10. 14. CPG Sec 500.450 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples. https://www.fda. gov/regulatory-information/search-fda-guidance- documents/cpg-sec-500450-volatile-n- nitrosamines- rubber-baby-bottle-nipples. 15. Perumal R, Leite M, van Zyl-Smit R. e Rela- tionship Between Clinical Trial Participation and Inhaler Technique Errors in Asthma and COPD Patients. Int J Chron Obstruct Pulmon Dis, 2020 Jun 2; 15:1217-1224. 16. Tashkin D, Celli B, Decramer M, Liu D, Bur- khart D, Cassino C, Kesten S. Bronchodilator Responsiveness in Patients with COPD. Eur Respir J, 2008; 31:742-750. 17. An Overview of In Vitro BE Studies, M. Javid- nia, Division of Generic Drug Study Integrity, Office of Study Integrity and Surveillance, Office of Trans- lational Sciences CDER, US FDA Office of Study Integrity and Surveillance (OSIS) Workshop 2022 - July 19, 2022, slides 22, 23 and 24. https://www.fda. gov/media/166004/download. 18. e Least Burdensome Provisions: Concept and Principles 4 Guidance for Industry and Food and Drug Administration Staff, https://www.fda.gov/ media/73188/download. 19. FDA Guidance: Submitting Separate Market- ing Applications and Clinical Data for Purposes of Assessing User Fees, 2005, https://www.fda.gov/ media/72397/download. 20. Referencing Approved Drug Products in ANDA Submissions Guidance for Industry, 2020. https:// www.fda.gov/media/102360/download.

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