5/7 runs · avg score 84%
Cross-benchmark category
FDA and Pharma Promotional Compliance
Compare AI agent runs for FDA and Pharma Promotional Compliance: prompts, scores, grades, and public traces. This page showcases APEX-Agents tasks that test whether AI agents can evaluate FDA and pharmaceutical promotional compliance, including off-label promotion, misbranding, 21 CFR Part 202, and CBE supplement scenarios.
Life sciences compliance AIOff-label promotion, 21 CFR Part 202, CBE supplements, misbranding
20Tasks
20Primary
1Benchmarks
Published model evidence
A quick view of shareable runs in this category. Open task and trace pages for the prompt, response, files, and grading details.
12/20 runs · avg score 70%
11/20 runs · avg score 67%
7/14 runs · avg score 71%
9/20 runs · avg score 60%
4/11 runs · avg score 56%
Primary tasks
20 tasks with this category as their main focus.
Using the research found on pharma marketing and articles around competitor shifts in SG&A spend, identify key trends that Impact can apply to SG&A spend that could reduce overall costs. In particular…
A doctor was recently charged by the federal government under the same regulations that were the subject of the case in "US v. Caronia, 703 F. 3d 149 - Court of Appeals, 2nd Circuit 2012.pdf" for pres…
Livyra has scrapped the "Focus on What Matters" campaign. They intend to replace it with a new campaign advertising to the general population which states normal approved audio messages based on depre…
For purposes of a training presentation for sales representatives giving background on what off-label promotion is and its legal status, please indicate whether it would be accurate to incorporate the…
Prepare an analysis regarding Livyra's Bencontra promotional activities. Take a look at the case file, paying close attention to the email communications as well as the relevant case law, statutes and…
Identify for each item below whether it could be used by the U.S. Food and Drug Administration (FDA) as evidence that Bencontra is intended by Livyra for use in pediatric patients: 1. bencontra_provi…
Based on new information showing increased reporting of seizures in Bencontra patients with no prior history of seizures, Livyra is planning to update the prescribing information for Bencontra to incl…
Livyra would like to put out a simple direct-to-consumer (DTC) advertisement for Bencontra. In an effort to avoid anything that could be construed as off-label promotion, the DTC advertisement would n…
You are an attorney. Please review the document regarding circulation issues associated with Bencontra. Does Livyra's dissemination of this document to a doctor who prescribes Bencontra appear to meet…
Review the attached email (stored as a docx file), as well as the cases available in the world. Write a message to me, outlining whether John’s actions constitute unlawful off-label promotion.
Analyze the attached report and the continuous manufacturing report to state the FDA-encouraged manufacturing style that differs from traditional methods which is mentioned in both reports. Using the …
Given the US imposed tariffs on the import of pharmaceutical materials from Germany, India, China at the rates 10%, 15%, 20% respectively, determine the impact of tariffs as a percent increase in pred…
Calculate the 2030E discounted EV/Revenue multiples for West Pharmaceutical, Stevanato Group, Schott Pharma, and Aptar Group. Reference the valuation model on the "Trading Comps" tab. Note that the fi…
Assume that 10% of Aptar's Asian pharma revenue will shift entirely into European pharma revenue. Retroactively apply this to 2024 financials. Refer to the 2024 ATR report. Return a short message with…
ATR is expecting to write down the goodwill related to Pharma to zero following the merger with GXI. Referring to the 2024 ATR 10K calculate the new total ending Goodwill under this write down scenari…
Create a new Spreadsheet for me. Please compute a new Adjusted EBITDA value for the following companies: West Pharmaceutical, Stevanato Group, Schlott Pharma, Berry Global, Aptar Group using the board…
In The Aptar Group's 2024 annual report, extract global revenue for the Pharma segment in 2023 and 2024. Compute the aggregate dollar change in thousands of USD adjusted for 7.1% 2024 global inflation…
From Becton Dickinson's FY2025 Annual Report assume the FDA finds that one violation regarding the Alaris SE infusion pumps, and decides the company is in violation, and enforces the consent decree on…
Livyra wants to market Bencontra using just its name and price. What is the correct type of advertisement Livyra can make, if any, and what conditions must the advertisement meet? Answer in one senten…
Livyra has decided to pay its independent contractors a fixed salary, consistent with fair market value, to sell Bencontra that is payable by government healthcare. Each independent contractor is give…