Pharmaceutical Policy

Drug approval, safety, pricing, and FDA drug/biologic rules.

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July 2026

Rulemaking

Notice · Environmental Protection Agency · Jul 22EPA

AR-226-0163 - Additional Characterizations of Metabolites of T-6292, T-6293 & T- 6294 from Rat and Human Hepatocytes by TurboIonSpray LC MS and LC/MS/MS. Semi- Quantitative Analysis of T-6295 in Rat and Human Hepatocytes Incubated with T-6292, T-6293 & T-6294 by LC/MS/MS

Notice · Environmental Protection Agency · Jul 22EPA

AR-226-0157 - Final Report: Single-Dose Intravenous Pharmacokinetic Study of T-6053 in Rabbits, with Protocol and in vivo Study No. AMDT- 010495.1

Notice · Food and Drug Administration · Jul 22FDA

Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Rasuvo (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter)

Notice · Food and Drug Administration · Jul 22FDA

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Notifications Submission

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_021254 - Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_212122 - Draft Guidance on Budesonide; Formoterol Fumarate; Glycopyrrolate

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_020503 - Draft Guidance on Albuterol Sulfate

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_021527 - Draft Guidance on Ipratropium Bromide

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_203214 - Draft Guidance on Tofacitinib Citrate

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_211379 - Draft Guidance on Dexamethasone

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_021658 - Draft Guidance on Ciclesonide

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_205739 - Draft Guidance on Patiromer Sorbitex Calcium

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_021929 - Draft Guidance on Budesonide; Formoterol Fumarate Dihydrate

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_022518 - Draft Guidance on Formoterol Fumarate; Mometasone Furoate

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_021395 - Draft Guidance on Tiotropium Bromide

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_210115 - Draft Guidance on Tacrolimus

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_009218-Sol - Draft Guidance on Warfarin Sodium

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_021433 - Draft Guidance on Fluticasone Propionate

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_212801 - Draft Guidance on Osilodrostat Phosphate

Comment period closed · Food and Drug Administration · Jul 22FDAClosed

PSG_019561 - Draft Guidance on Potassium Chloride

Upcoming deadlines

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec

FDA · Comment closes · Jul 30

DEA · Comment closes · Jul 31

DEA · Comment closes · Jul 31

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

FDA · Comment closes · Jul 31

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

FDA · Comment closes · Aug 1

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