Pharmaceutical Policy

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

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July 2026

Rulemaking

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

Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

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

Citizen Petition from Apotex Inc.

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Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Rasuvo (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter)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PSG_021254 - Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate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PSG_212122 - Draft Guidance on Budesonide; Formoterol Fumarate; Glycopyrrolate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PSG_020503 - Draft Guidance on Albuterol Sulfate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PSG_021527 - Draft Guidance on Ipratropium Bromide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PSG_203214 - Draft Guidance on Tofacitinib Citrate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PSG_211379 - Draft Guidance on Dexamethasone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PSG_021658 - Draft Guidance on Ciclesonide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PSG_205739 - Draft Guidance on Patiromer Sorbitex Calcium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

Upcoming deadlines

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry

FDA · Comment closes · Sep 2

Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements

FDA · Comment closes · Sep 5

Reducing Barriers to Medical Use Licensing

NRC · Comment closes · Sep 11

Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

FDA · Comment closes · Sep 12

Medicare and Medicaid Programs: Calendar Year 2027 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

CMS · Comment closes · Sep 15

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