Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability
Published . Updated .
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Potency Assurance for Cellular and Gene Therapy Products." The guidance document provides recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, we describe how to progressively implement a strategy for potency assurance during product development and provide additional considerations to help assure the potency of products that are undergoing rapid clinical development. For licensed products, we describe requirements for potency assurance, including testing required for lot release assays. The guidance announced in this notice finalizes the draft guidance of the same title issued on December 28, 2023.
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.
- LLY Eli Lilly and+19.9% 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+1.9% 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+7.3% 30d
Pfizer (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- MRK Merck+5.9% 19d
Merck (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
Price reaction, T-5 to T+3
| Ticker | T-5 | T-3 | T-1 | T0 | T+1 | T+2 | T+3 |
|---|---|---|---|---|---|---|---|
| XLVNo price data for this ticker | — | — | — | — | — | — | — |
| XBINo price data for this ticker | — | — | — | — | — | — | — |
| LLYNo price data for this ticker | — | — | — | — | — | — | — |
| JNJNo price data for this ticker | — | — | — | — | — | — | — |
| PFENo price data for this ticker | — | — | — | — | — | — | — |
| MRKNo price data for this ticker | — | — | — | — | — | — | — |
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.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Potency Assurance for Cellular and Gene Therapy Products." The guidance document provides recommendations to help assure the potenc…
Source: Federal Register
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 59 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 33 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 38 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 55 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 59 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 73 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 39 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 75 days before publication. Filed 9 Sep 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).
This story
25 out of 100
“Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability” scores 25 out of 100. The score uses 2 sources.