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Sasha Latypova and Katherine Watt discussing non-regulation of non-medicines known as 'vaccines,' and other US military biochemical weapons.
21 USC 360bbb, FDCA Section 561, FDCA Section 564, etc.
Nov. 4, 2023 - Do C-19 Vax Manufacturers Violate cGxP? (Sasha Latypova)
Nov. 7, 2023 - Sasha Latypova and Katherine Watt talking about non-regulation of non-medicines. (Link to Rumble video, 38 min)
US Code, Title 21, Food and Drugs, Chapter 9, Federal Food Drug and Cosmetics Act (FDCA).
Notes include title/topic and year passed by US Congress,1 signed by US Presidents. Most provisions have been amended many times since 1997 when the foundation was laid.
21 USC 360bbb = FDCA Section 561, Expanded access to unapproved therapies and diagnostics. Added 1997.
21 USC 360bbb-0 = FDCA Section 561A, Expanded access policy required for investigational drugs. Added 2016.
21 USC 360bbb-0a = FDCA Section 561B, Investigational drugs for use by eligible patients. Added 2018.
21 USC 360bbb-1 = FDCA Section 562, Dispute resolution. Added 1997.
21 USC 360bbb-2 = FDCA Section 563, Classification of products. Added 1997.
21 USC 360bbb-3 = FDCA Section 564, Authorization for medical products for use in emergencies [Legal conditions governing product manufacturing] - “…the use of such product…shall not be considered to constitute a clinical investigation…” Added 2003.
21 USC 360bbb-3a = FDCA 564A, Emergency use of medical products. [Legal conditions governing product use.] Added 2013.
21 USC 360bbb-3b = FDCA 564B, Products held for emergency use. [Legal conditions governing product stockpiling and “introduction into interstate commerce.” Added 2013.
21 USC 360bbb-3c = [Enacted as part of PL 115-92; not entered into the FDCA], Expedited development and review of medical products for emergency uses. Added 2017.
21 USC 360bbb-4 = FDCA 565, Countermeasure development, review and technical assistance. Added 2006.
21 USC 360bbb-4a = FDCA 565A, Priority review to encourage treatments for agents that present national security threats. Added 2016.
21 USC 360bbb-4b = FDCA 565B, Medical countermeasures master files. Added 2019.
21 USC 360bbb-5 = FDCA 566, Critical Path Public-Private Partnerships. Added 2007.
21 USC 360bbb-5a = FDCA 566A, Emerging Technology Program. Added 2022.
21 USC 360bbb-6 = FDCA 567, Risk communication. Added 2007.
21 USC 360bbb-7 = FDCA 568, Notification. Added 2012.
21 USC 360bbb-8 = FDCA 569, Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments. Added 2012.
21 USC 360bbb-8a = FDCA 569A, Optimizing global clinical trials. Added 2012.
21 USC 360bbb-8b = FDCA 569B, Use of clinical investigation data from outside the United States. Added 2012.
21 USC 360bbb-8c = FDCA 569C, Patient participation in medical product discussion. Added 2012.
21 USC 360bbb-8d = FDCA 569D, Notification, nondistribution, and recall of controlled substances. Added 2018.
FDA Legal Preparedness Slide Decks (partial list)
Related Bailiwick reporting and analysis:
April 25, 2022 - The investigational drugs that weren’t.
Nov. 22, 2022 - Stopping conditions.
1997 - Food and Drug Administration Modernization Act
2002 - Public Health Security and Bioterrorism Preparedness and Response Act
2002 - Homeland Security Act of 2002
2003 - National Defense Authorization Act FY2004 (NDAA)
2004 - Project Bioshield Act
2005 - Public Readiness and Emergency Preparedness Act (PREP)
2006 - Pandemic and All-Hazards Preparedness Act (PAHPA)
2007 - NIH Reform Act of 2006
2007 - Food and Drug Administration Amendments Act of 2007
2012 - Food and Drug Administration Safety and Innovation Act
2013 - Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)
2016 - 21st Century CURES Act
2017 - FDA Reauthorization Act of 2017
2017 - National Defense Authorization Act FY2018 (NDAA)
2017 - An Act To amend the Federal Food, Drug, and Cosmetic Act to authorize additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war, and for other purposes.
2018 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act
2018 - Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment [SUPPORT Act] for Patients and Communities Act
2019 - Pandemic and All-Hazards Preparedness and Advancing Innovations Act
2021 - An Act to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity
2022 - Continuing Appropriations and Ukraine Supplemental Appropriations Act, Division F: FDA User Fee Reauthorization Act Of 2022
2022 - Further Continuing Appropriations and Extensions Act, 2023
2022 - Consolidated Appropriations Act; Division FF - Health and Human Services