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Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Rasuvo (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter)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PSG_021254 - Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate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PSG_212122 - Draft Guidance on Budesonide; Formoterol Fumarate; Glycopyrrolate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PSG_020503 - Draft Guidance on Albuterol Sulfate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PSG_021527 - Draft Guidance on Ipratropium Bromide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PSG_203214 - Draft Guidance on Tofacitinib Citrate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PSG_211379 - Draft Guidance on Dexamethasone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PSG_021658 - Draft Guidance on Ciclesonide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PSG_205739 - Draft Guidance on Patiromer Sorbitex Calcium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

Expedited Investigational New Drug Pilot Program; Request for Information

FDA · Comment closes · Aug 25

Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period

FDA · Comment closes · Aug 25

Information Collection: NRC Form 313, Application for Materials License and NRC Forms 313A (Radiation Safety Officer (RSO)), 313A (AMP), 313A (Authorized Nuclear Pharmacist (ANP)), 313A (Authorized User Training, Experience and Preceptor Attestation (AUD)), 313A (Authorized User Training, Experience, and Preceptor Attestation (AUT)), and 313A (Authorized User Training, Experienced Preceptor Attest

NRC · Comment closes · Aug 25

Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products

FDA · Comment closes · Aug 26

Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products

FDA · Comment closes · Aug 26

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