Extract to table
Pull the structured facts out of a document: parties, dates, amounts, obligations.
Extract to table / preliminary-assessment-memo.docx
preliminary-assessment-memo.docx
Parties
Harkness LLP
Regulatory Affairs Penterra Pharmaceuticals Corp
Penterra Pharmaceuticals Corp
Associates LLP
Ridgeline Health Analytics LLC
M. Witherspoon
Keswick Bioanalytics Inc
Tavrenis Stern Consulting Group LLC
Dates
November 6, 2023
October 12, 2023
October 16, 2023
October 11, 2019
November 3, 2023
November 1, 2023
November 15, 2023
January 15, 2024
November 8, 2023
March 15, 2021
Amounts
$814.6
$2.18
$612.3
$816.4
$6.9
$3.4
$1.85
$950
$625
$87,500
Obligations
1(e)(5), prescription drug advertisements must present "a true statement of information in brief summary relating to side effects, contraindications, and effectiveness" and must present a "fair balance" between information about a drug's effectiveness and information about its risks
We caution that this fact must be handled with care in the FDA response
1(e)(6), promotional materials for prescription drugs must not present data in a misleading manner or cite studies that lack adequate scientific rigor to support the claims being made