FDA finalizes guidance on prescription drug use-related software
Published . Updated .
Key takeaways
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FDA’s final guidance on prescription drug use-related software explains when app output counts as labeling and what sponsors must submit.
Directly affected
- No company is named in this report.
Indirectly affected
- XLV Health Care Select Sector SPDR
Health Care Select Sector SPDR: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story.
- XBI SPDR S&P Biotech ETF
SPDR S&P Biotech ETF: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story.
- IGV iShares Expanded Tech-Software ETF+7.2% 7d
iShares Expanded Tech-Software ETF: it holds software companies. Linked by “software” (software) in this story.
- LLY Eli Lilly and+20.6% 30d
Eli Lilly and (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- JNJ Johnson & Johnson+0.5% 30d
Johnson & Johnson (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- PFE Pfizer+9.0% 30d
Pfizer (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- MRK Merck+4.6% 17d
Merck (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- MSFT Microsoft+1.8% 30d
Microsoft (prepackaged software): software firms move with business tech spending. Linked by “software” (software) in this story.
Price reaction, T-5 to T+3
| Ticker | T-5 | T-3 | T-1 | T0 | T+1 | T+2 | T+3 |
|---|---|---|---|---|---|---|---|
| XLV | -2.31% | +0.48% | base | after close | after close | after close | after close |
| XBI | +1.67% | +0.67% | base | after close | after close | after close | after close |
| IGV | +8.99% | +1.60% | base | after close | after close | after close | after close |
| LLY | -8.42% | +0.54% | base | after close | after close | after close | after close |
| JNJ | +1.93% | +2.66% | base | after close | after close | after close | after close |
| PFE | -1.67% | +1.73% | base | after close | after close | after close | after close |
| MRK | -2.47% | +3.37% | base | after close | after close | after close | after close |
| MSFT | +2.19% | +0.22% | base | after close | after close | after close | after close |
Closing-price change versus T-1, the last close before the story. T0 to T+3 fill in after each market close. Prices: Alpaca IEX.
FDA finalizes guidance on prescription drug use-related software McDermott Will & Schulte
Source: McDermott Will & Schulte
Price since this story was published: Select Sector Spdr Tr (XLV)
| Company | When | Move | Status |
|---|---|---|---|
| Ishares Tr (IGV) | three days earlier | +1.60% | final price |
| Ishares Tr (IGV) | five days earlier | +8.99% | final price |
| Johnson & Johnson (JNJ) | three days earlier | +2.66% | final price |
| Johnson & Johnson (JNJ) | five days earlier | +1.93% | final price |
| Eli Lilly (LLY) | three days earlier | +0.54% | final price |
| Eli Lilly (LLY) | five days earlier | -8.42% | final price |
| Merck (MRK) | three days earlier | +3.37% | final price |
| Merck (MRK) | five days earlier | -2.47% | final price |
| Microsoft (MSFT) | three days earlier | +0.22% | final price |
| Microsoft (MSFT) | five days earlier | +2.19% | final price |
| Pfizer (PFE) | three days earlier | +1.73% | final price |
| Pfizer (PFE) | five days earlier | -1.67% | final price |
| Spdr Series Trust (XBI) | three days earlier | +0.67% | final price |
| Spdr Series Trust (XBI) | five days earlier | +1.67% | final price |
| Select Sector Spdr Tr (XLV) | three days earlier | +0.48% | final price |
| Select Sector Spdr Tr (XLV) | five days earlier | -2.31% | final price |
Trades by members of Congress and officials in the stocks in this story
- Rep. Rohit Khanna bought Eli Lilly (LLY) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 61 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Thomas H. Kean Jr sold Johnson & Johnson (JNJ), worth $1,001 - $15,000 on 30 Sep 2026. That is 35 days before publication. Filed 30 Oct 2026. View the filing.
- Rep. Rohit Khanna bought Johnson & Johnson (JNJ) (held by a spouse), worth $1,001 - $15,000 on 25 Sep 2026. That is 40 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Lloyd Doggett bought Johnson & Johnson (JNJ), worth $1,001 - $15,000 on 8 Sep 2026. That is 57 days before publication. Filed 5 Oct 2026. View the filing.
- Rep. Rohit Khanna sold Pfizer (PFE) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 61 days before publication. Filed 7 Oct 2026. View the filing.
- Donald J Trump, an executive branch official, bought Pfizer (PFE), worth $100,001 - $250,000 on 21 Aug 2026. That is 75 days before publication. Filed 8 Oct 2026. View the filing.
- Rep. Maria Elvira Salazar sold Merck (MRK), worth $1,001 - $15,000 on 24 Sep 2026. That is 41 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Maria Elvira Salazar bought Merck (MRK), worth $15,001 - $50,000 on 19 Aug 2026. That is 77 days before publication. Filed 9 Sep 2026. View the filing.
- Rep. Pete Sessions sold Microsoft (MSFT) (held by a spouse), worth $250,001 - $500,000 on 2 Oct 2026. That is 33 days before publication. Filed 27 Oct 2026. View the filing.
- Rep. Lisa McClain bought Microsoft (MSFT) (held by a spouse), worth $1,001 - $15,000 on 30 Sep 2026. That is 35 days before publication. Filed 12 Oct 2026. View the filing.
- Rep. Michael Rulli sold Microsoft (MSFT), worth $1,001 - $15,000 on 28 Sep 2026. That is 37 days before publication. Filed 2 Oct 2026. View the filing.
Public disclosure filings, not a recommendation. The filing link is the source document. News use of these reports still sits under 5 U.S.C. § 13107(c).
Who gains and who loses around Select Sector Spdr Tr (XLV)
Companies tied to this story
- XLV Select Sector Spdr Tr
In “FDA finalizes guidance on prescription drug use-related software,” Select Sector Spdr Tr (XLV) is linked, with no stored direction, medium confidence. Reason on file: Health Care Select Sector SPDR: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story
- XBI Spdr Series Trust
Spdr Series Trust (XBI) is linked, with no stored direction, medium confidence in the 4 Nov 2026 story “FDA finalizes guidance on prescription drug use-related software.” Reason on file: SPDR S&P Biotech ETF: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story
- IGV Ishares Tr
For “FDA finalizes guidance on prescription drug use-related software,” Ishares Tr (IGV) is linked, with no stored direction, medium confidence. Reason on file: iShares Expanded Tech-Software ETF: it holds software companies. Linked by “software” (software) in this story
- LLY Eli Lilly
In “FDA finalizes guidance on prescription drug use-related software,” Eli Lilly (LLY) is linked, with no stored direction, medium confidence. Reason on file: Eli Lilly and (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story
- JNJ Johnson & Johnson
Johnson & Johnson (JNJ) is linked, with no stored direction, medium confidence in the 4 Nov 2026 story “FDA finalizes guidance on prescription drug use-related software.” Reason on file: Johnson & Johnson (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story
- PFE Pfizer
In “FDA finalizes guidance on prescription drug use-related software,” Pfizer (PFE) is linked, with no stored direction, medium confidence. Reason on file: Pfizer (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story
- MRK Merck
For “FDA finalizes guidance on prescription drug use-related software,” Merck (MRK) is linked, with no stored direction, medium confidence. Reason on file: Merck (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story
- MSFT Microsoft
Microsoft (MSFT) is linked, with no stored direction, medium confidence in the 4 Nov 2026 story “FDA finalizes guidance on prescription drug use-related software.” Reason on file: Microsoft (prepackaged software): software firms move with business tech spending. Linked by “software” (software) in this story
Select Sector Spdr Tr (XLV)
On 4 Nov 2026, “FDA finalizes guidance on prescription drug use-related software” is the story that connects Select Sector Spdr Tr (XLV) to this story.
Select Sector Spdr Tr (XLV) is on the page because Health Care Select Sector SPDR: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story
Spdr Series Trust (XBI) is here too. Its reason reads: SPDR S&P Biotech ETF: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story
Dates in the story, and the Select Sector Spdr Tr (XLV) price range
IGV traded between 108.83 and 112.61 across 4 sessions. The latest close on file is 112.59.
How strong the case is around Select Sector Spdr Tr (XLV)
46 out of 100
“FDA finalizes guidance on prescription drug use-related software” scores 46 out of 100. The score uses 1 sources, and 8 linked companies.