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21st Century Cures Act: COVID-19 Plandemic Architected by USA Federal Government

Anonymous Tue 03 Oct 2023 23:16:05 No.1222256 View View Reply Original Report

Quoted By:

Congress.gov: 21st Century Cures Act
https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf

FDA and DHS published this "Act" in 2016, threee years before Trump formally declared the Plandemic.
Reading even half of the Act, it is obvious that the formalization of biological warfare on intrastate populations is advanced through rewriting laws to protect unlicensed and unmitigated drugs from being disseminated to a population.

The Secretary of Health is given broad powers to override previous Acts insofar as in his Department's discretion they think some drug or TREATMENT aligns with the goal of THIS act.

https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf

Every qualification for exceptoins in previous Acts is given an antiqualification or exception in THIS Act.
Key sections coming up...

Anonymous

Anonymous Tue 03 Oct 2023 23:17:48 No.1222257 Report

Quoted By:

‘(9) SURROGATE ENDPOINT.—The term ‘surrogate endpoint’
means a marker, such as a laboratory measurement, radio-
graphic image, physical sign, or other measure, that is not
itself a direct measurement of clinical benefit, and—
‘‘(A) is known to predict clinical benefit and could be
used to support traditional approval of a drug or biological
product; or
‘‘(B) is reasonably likely to predict clinical benefit and
could be used to support the accelerated approval of a
drug or biological product in accordance with section
506(c).’’

Anonymous

Anonymous Tue 03 Oct 2023 23:19:07 No.1222259 Report

Quoted By:

‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed—
‘‘(1) to alter the standards of evidence under subsection
(c) or (d) of section 505, including the substantial evidence
standard in such subsection (d), or under section 351 of the
Public Health Service Act (as applicable); or
‘‘(2) to limit the authority of the Secretary to approve
or license products under this Act or the Public Health Service
Act, as applicable (as in effect before the date of the enactment
of the 21st Century Cures Act).

‘‘(2) to limit the authority of the Secretary to approve
or license products under this Act
‘‘(2) to limit the authority of the Secretary to approve
or license products under this Act
‘‘(2) to limit the authority of the Secretary to approve
or license products under this Act
‘‘(2) to limit the authority of the Secretary to approve
or license products under this Act
‘‘(2) to limit the authority of the Secretary to approve
or license products under this Act

Anonymous

Anonymous Tue 03 Oct 2023 23:20:08 No.1222260 Report

Quoted By:

‘(3) CLINICAL OUTCOME ASSESSMENT.—The term ‘clinical
outcome assessment’ means—
‘‘(A) a measurement of a patient’s symptoms, overall
mental state, or the effects of a disease or condition on
how the patient functions; and
‘‘(B) includes a patient-reported outcome.
‘‘(4) CONTEXT OF USE.—The term ‘context of use’ means,
with respect to a drug development tool, the circumstances
under which the drug development tool is to be used in drug
development and regulatory review.
‘‘(5) DRUG DEVELOPMENT TOOL.—The term ‘drug develop-
ment tool’ includes—
‘‘(A) a biomarker;
‘‘(B) a clinical outcome assessment; and
‘‘(C) any other method, material, or measure that the
Secretary determines aids drug development and regu-
latory review for purposes of this section.

any other method... that the
Secretary determines aids drug development
any other method... that the
Secretary determines aids drug development
any other method... that the
Secretary determines aids drug development
any other method... that the
Secretary determines aids drug development

Anonymous

Anonymous Tue 03 Oct 2023 23:22:05 No.1222261 Report

Quoted By:

30 STAT. 1089PUBLIC LAW 114–255—DEC. 13, 2016
‘‘(A) means a characteristic (such as a physiologic,
pathologic, or anatomic characteristic or measurement) that
is objectively measured and evaluated as an indicator of
normal biologic processes, pathologic processes, or biological
responses to a therapeutic intervention; and
‘‘(B) includes a surrogate endpoint.
‘‘(2) BIOMEDICAL RESEARCH CONSORTIA.—The term ‘bio-
medical research consortia’ means collaborative groups that
may take the form of public-private partnerships and may
include government agencies, institutions of higher education
(as defined in section 101(a) of the Higher Education Act of
1965), patient advocacy groups, industry representatives, clin-
ical and scientific experts, and other relevant entities and
individuals.

means a characteristic... includes a surrogate endpoint.
SURROGATE ENDPOINT.
means a marker, that is not itself a direct measurement of clinical benefit, and is reasonably likely to predict clinical benefit
reasonably likely to predict
reasonably likely to predict
reasonably likely to predict
reasonably likely to predict
reasonably likely to predict

Anonymous

Anonymous Tue 03 Oct 2023 23:23:14 No.1222263 Report

Quoted By:

SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED
THERAPIES.

‘(B) the drug is intended to treat, modify, reverse,
or cure a serious or life-threatening disease or condition;
and

‘(6) ACCESS TO EXPEDITED APPROVAL PATHWAYS.—An
application for a regenerative advanced therapy under section
505(b)(1) of this Act or section 351(a) of the Public Health
Service Act may be—
‘‘(A) eligible for priority review, as described in the
Manual of Policies and Procedures of the Food and Drug
Administration and goals identified in the letters described
in section 101(b) of the Prescription Drug User Fee Amend-
ments of 2012; and
‘‘(B) eligible for accelerated approval under subsection
(c), as agreed upon pursuant to subsection (a)(3)(B),
through, as appropriate—
‘‘(i) surrogate or intermediate endpoints reasonably
likely to predict long-term clinical benefit; or
‘‘(ii) reliance upon data obtained from a meaningful
number of sites, including through expansion to addi-
tional sites, as appropriate.
‘‘(B) eligible for accelerated approval under subsection
(c),
including through expansion to addi-
tional sites, as appropriate.
‘‘(B) eligible for accelerated approval under subsection
(c),
including through expansion to addi-
tional sites, as appropriate.
‘‘(B) eligible for accelerated approval under subsection
(c),
including through expansion to addi-
tional sites, as appropriate.
‘‘(B) eligible for accelerated approval under subsection
(c),
including through expansion to addi-
tional sites, as appropriate.
‘‘(B) eligible for accelerated approval under subsection
(c),
including through expansion to addi-
tional sites, as appropriate.

Anonymous

Anonymous Tue 03 Oct 2023 23:25:15 No.1222267 Report

Quoted By:

The COVID Plandemic was architected to perform largescale biological experiments on national populations by their own governments.
The added bonus of forcing podpeople to stay home and spend their entire waking life in front of a computer screen through rewriting Computer Professional overtime laws further substantiates the conspiracy.

This didn't take ten years to iron out and prove as in 9/11. This was pretty much in our faces the entire time.

Anonymous

Anonymous Tue 03 Oct 2023 23:28:59 No.1222268 Report

Quoted By: >>1222327 >>1222329

This isn't a news article. And even if it was, it's older than 48 hours.

Anonymous

Anonymous Wed 04 Oct 2023 02:47:54 No.1222327 Report

Quoted By: >>1222329

>>1222268
Clutch your shit harder than you do with your chest from your barrage of heart attacks vaxxed golem.

Anonymous

Anonymous Wed 04 Oct 2023 02:50:33 No.1222329 Report

Quoted By:

>>1222268
I would call releases directly from the government news, personally
>>1222327
And look at the board rules for that 48 hour rule, fuckface.

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