Small Business Warning Letter

Save, fill-In The Blanks, Print, Done!

Click on image to zoom / Click button below to see more images
Adobe Acrobat (.pdf)

  • This Document Has Been Certified by a Professional
  • 100% customizable
  • This is a digital download (112.28 kB)
  • Language: English
  • We recommend downloading this file onto your computer.

ABT template rating: 7

Malware- and virusfree. Scanned by: Norton safe website

Are you looking for a professional Small Business Warning Letter? If you've been feeling stuck or lack motivation, download this template now!

Do you have an idea of what you want to draft, but you cannot find the exact words yet to write it down or lack the inspiration how to make it? If you've been feeling stuck, this Small Business Warning Letter template can help you find inspiration and motivation. This Small Business Warning Letter covers the most important topics that you are looking for and will help you to structure and communicate in a professional manner with those involved. 

Background According to its FDA-approved product labeling (PI): Dacogen is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and Intermediate-1, Intermediate-2, and High-Risk International Prognostic System groups.. The DOSAGE AND ADMINISTRATION section of the PI states (in pertinent part): Dose Adjustment or Delay Based on Hematology Laboratory Values If hematologic recovery (ANC ≥ 1,000/μL and platelets ≥ 50,000/μL) from a previous Dacogen treatment cycle requires more than 6 weeks, then the next cycle of Dacogen therapy should be delayed and dosing temporarily reduced by following this algorithm: • Recovery requiring more than 6, but less than 8 weeks - Dacogen dosing to be delayed for up to 2 weeks and the dose temporarily reduced to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy.. The card also includes the following claim and presentation: • “DACOGEN PROVIDES BENEFIT IN RAEB-T PATIENTS”1,6 (“Gil”) in conjunction with: o A graph that shows a 54 “Clinical benefit (stable disease or better),” and an 18 “Complete or partial response rate” for these patients (N=17) o A footnote that defines “stable disease” as “failure to achieve at least a PR but with no evidence of progression for at least 2 months.” o A footnote that defines “clinical benefit” as “patients achieving complete response (CR) + partial response (PR) + hematological improvement (HI described by magnitude of response major or minor and individual responsive cell lines) + stable disease (SD)” (footnote omitted) These claims regarding the efficacy of Dacogen in RAEB-T patients are not substantiated.. As stated in the PI, in the Phase 3 trial, “ s

Feel free to download this intuitive template that is available in several kinds of formats, or try any other of our basic or advanced templates, forms or documents. Don't reinvent the wheel every time you start something new... 

Download this Small Business Warning Letter template and save yourself time and efforts! You will see completing your task has never been simpler!

Nothing on this site shall be considered legal advice and no attorney-client relationship is established.

Leave a Reply. If you have any questions or remarks, feel free to post them below.

default user img

Get busy living or get busy dying. | from the “The Shawshank Redemption”