More FDA Forms for Desperate Patients' Wonder Drugs
Published Date: 10/9/2026
Notice
Summary
The FDA is updating how it collects info to help patients with serious or life-threatening conditions get access to experimental drugs when no other treatments work. This change affects doctors, drug makers, and patients by streamlining paperwork and making the process clearer. Comments on these updates are open until November 9, 2026, with no new costs expected.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Large annual paperwork burden reduction reported
FDA reports that, upon its most recent review, the information collections reflect a cumulative decrease of 11,767 responses and 236,308 burden hours annually across the collections related to expanded access submissions.
Form FDA 3926 data-field and heading changes
FDA is revising Form FDA 3926 (Individual Patient Expanded Access IND). In Field 6 the data element "Investigational Drug Name" is deleted and replaced with "Planned Date of Treatment Initiation," and "FDA Review Division (if known)" is revised to "FDA Office/Review Division (if known)." In Field 9 the heading is changed to "Contents of Submission (follow-up/additional submissions only)." FDA also states respondents may continue to use either Form FDA 3926 or Form FDA 1571 for IND submissions, and a completed Form FDA 3926 signed by the physician with the box in Field 10.a checked is treated as a waiver request under 21 CFR 312.10.
No capital or operating costs for information collection
FDA states there are no capital costs or operating and maintenance costs associated with this collection of information for the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20730, Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction
The FDA fixed a previous announcement about pulling approval for 16 generic drug applications. Three drugs from Navinta LLC—ribavirin solution, fosaprepitant powder, and nicardipine capsules—won't lose approval because Navinta asked to keep them active. This means those three drugs stay on the market, while the other 13 still had their approvals withdrawn as planned back in July 2026.
Previous / Next Documents
Previous: 2026-20764, Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA has decided that LASIX oral solution (10 mg/mL) wasn’t taken off the market because of safety or effectiveness problems. This means generic drug makers can keep getting approval to sell their versions of LASIX, keeping options open for patients and pharmacies. No changes in price or availability are expected, so everyone who relies on this medicine can breathe easy!
Next: 2026-20766, Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC
The FDA has officially set the review period for MONOFERRIC, a human drug, which helps the company extend its patent protection. This means the drug maker could get extra time to keep their invention exclusive, potentially affecting competition and market prices. If anyone thinks the dates are wrong or wants to challenge the company’s diligence, they have until late 2026 or early 2027 to speak up.