Not to be confused with You Have No Chance to Survive, which is when the antagonist simply says "Your days are numbered!" or something similar, as a threat. Unless Alice is actually doomed, the statement in itself is that, not this.
My Days Are Numbered – Someone Wants Me Dead!
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Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) requires submission of results information for applicable clinical trials (ACTs) that were initiated after September 27, 2007, or that were ongoing as of December 26, 2007, if the product studied in the ACT is approved, licensed, or cleared by the Food and Drug Administration (FDA) at any time, including after the ACT's primary completion date. For ACTs subject to FDAAA's registration and results submission requirements that have a primary completion date before January 18, 2017 (the effective date of the Final Rule), results information must be submitted as follows:If the ACT studied a drug, biological, or device product that was approved, licensed, or cleared by FDA before the ACT's primary completion date, the responsible party generally must submit the results information specified in section 402(j)(3)(C) and section 402(j)(3)(I) of the Public Health Service (PHS) Act no later than 1 year after the study's primary completion date; however, results information submission for these ACTs may be delayed under certain conditions as specified in section 402(j)(3)(E)(v) (seeking approval, licensing, or clearance of a new use for the drug, biological, or device product) and section 402(j)(3)(E)(vi) (requesting an extension for good cause) of the PHS Act.
Pursuant to the Federal Court decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020), if the ACT studied a drug, biological, or device product that was not approved, licensed, or cleared for any use as of the primary completion date but is subsequently approved, licensed, or cleared by FDA on or after the ACT's primary completion date, the responsible party must submit the results information specified in section 402(j)(3)(C) and section 402(j)(3)(I) of the PHS Act within 30 days after approval, licensure, or clearance of the drug, biological, or device product, in accordance with section 402(j)(3)(E)(iv) of the PHS Act (seeking initial approval, licensure, or clearance of the drug, biological, or device product) and may be delayed under certain conditions as specified in section 402(j)(3)(E)(vi) (requesting an extension for good cause) of the PHS Act.
If the results submission deadline has already passed for an ACT affected by the Federal Court decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020), what is the deadline for submitting results information?
The deadline for the delayed submission of results information as specified in 42 CFR 11.44(b) or 42 CFR 11.44(c) is 30 calendar days after the earliest of specific events described in each provision, with a maximum deadline for delayed results information submission of 2 years after the date the certification was submitted. Specific deadlines are also described in 42 CFR 11.44(d) for the submission of partial results information. An extension for good cause may be requested prior to the date (i.e., the day before) that results information would otherwise be due as specified in 42 CFR 11.44(e). The preamble of the final rule explains that such requests will be granted in limited circumstances. (81 FR 65076-79)
The regulation at 42 CFR 11.44(e)(3) permits a responsible party to appeal a denied request for an extension of the deadline for submitting not later than 30 calendar days after the date on which the electronic notification of the granting or denial of the request is sent to the responsible party. An appeal must provide an explanation of the reason(s) why the initial decision to deny the request or grant the request with a shorter deadline than requested should be overturned or revised, with sufficient detail to allow for the evaluation of the appeal. Responsible parties should provide further elaboration of the grounds for the request or highlight factors that justify an extension. The appeal should only address why the initial decision was incorrect; new bases for an extension request should not be presented for the first time in an appeal and will not be considered. Only one appeal may be submitted for a denied request.
Under 42 CFR 11.44(c), a responsible party may submit a certification ("certify initial approval") prior to the date of (i.e., the day before) the standard submission deadline for results information specified in 42 CFR 11.44(a) to indicate that an ACT studies an FDA-regulated drug, biological, or device product that was not approved, licensed, or cleared by FDA for any use before the trial's primary completion date, and that the sponsor intends to continue with product development and is either seeking, or may at a future date seek, FDA approval, licensure, or clearance of the studied product. In this case, the deadline for results information submission is 30 days after the earlier of: FDA approval, licensure, or clearance of the product for any use that is studied in the ACT, or
The marketing application or premarket notification is withdrawn without resubmission for not less than 210 calendar days.
The regulation also states in 42 CFR 11.44(c) that the maximum deadline for results information submission is 2 years after the date on which the certification was submitted, except to the extent that 42 CFR 11.44(d), which pertains to the submission of partial results information, applies.
In this case, the deadline for results information submission is 30 days after the earlier of:FDA approval, licensure, or clearance of the product for any use that is studied in the ACT,
FDA issuing a letter that ends the regulatory review cycle for the application or submission but does not approve, license, or clear the product, or
The marketing application or premarket notification is withdrawn without resubmission for not less than 210 calendar days.
If none of the above events occurs, then the maximum deadline for results information submission is 2 years after the date on which the certification was submitted, except to the extent that 42 CFR 11.44(d), which pertains to the submission of partial results information, applies. 2ff7e9595c
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