Nonrulemaking

Industry Describing Product-Specific Bioequivalence Recommendations

🏛 Food and Drug Administration (FDA)FDA-2007-D-0369

Mental Health & Substance Abuse Pharmaceutical Policy Tobacco & Nicotine Products

Documents

Total comments

all analyzed

Comment status

Open

Last activity

—

In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

All 73 Other 72 Notice 1

📄 Primary document

OtherMay 22, 2026

PSG_020503 - Draft Guidance on Albuterol Sulfate

Closed on Jul 22, 2026

Open →

Other· May 22, 2026
PSG_214070 - Draft Guidance on Albuterol Sulfate; Budesonide→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_219423 - Draft Guidance on Amlodipine Besylate; Indapamide; Telmisartan→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_210745 - Draft Guidance on Apremilast→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_202971 - Draft Guidance on Aripiprazole→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_218643 - Draft Guidance on Articaine Hydrochloride→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_219208 - Draft Guidance on Atrasentan Hydrochloride→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_219616 - Draft Guidance on Avutometinib Potassium; Defactinib Hydrochloride→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_207921 - Draft Guidance on Beclomethasone Dipropionate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_020911 - Draft Guidance on Beclomethasone Dipropionate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_216579 - Draft Guidance on Budesonide; Formoterol Fumarate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021929 - Draft Guidance on Budesonide; Formoterol Fumarate Dihydrate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_212122 - Draft Guidance on Budesonide; Formoterol Fumarate; Glycopyrrolate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_209819 - Draft Guidance on Buprenorphine→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_215499 - Draft Guidance on Cabotegravir→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_212888 - Draft Guidance on Cabotegravir; Rilpivirine→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_219921 - Draft Guidance on Carboplatin→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_050406 - Draft Guidance on Cephalexin→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021658 - Draft Guidance on Ciclesonide→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_050767 - Draft Guidance on Clindamycin Phosphate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_213491 - Draft Guidance on Cysteamine Bitartrate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_203389 - Draft Guidance on Cysteamine Bitartrate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_020392 - Draft Guidance on Cysteamine Bitartrate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_211379 - Draft Guidance on Dexamethasone→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_208742 - Draft Guidance on Dexamethasone→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_022122 - Draft Guidance on Diclofenac Sodium→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_219876 - Draft Guidance on Dordaviprone Hydrochloride→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_020126 - Draft Guidance on Doxepin Hydrochloride→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_212725 - Draft Guidance on Entrectinib→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_205920 - Draft Guidance on Epinephrine→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021957 - Draft Guidance on Esomeprazole Magnesium→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_212102 - Draft Guidance on Fenfluramine Hydrochloride→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_215341 - Draft Guidance on Finerenone→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_219019 - Draft Guidance on Fitusiran Sodium→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021247 - Draft Guidance on Flunisolide→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021433 - Draft Guidance on Fluticasone Propionate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021254 - Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_208294 - Draft Guidance on Formoterol Fumarate; Glycopyrrolate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_022518 - Draft Guidance on Formoterol Fumarate; Mometasone Furoate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_217779 - Draft Guidance on Imetelstat Sodium→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021527 - Draft Guidance on Ipratropium Bromide→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_215974 - Draft Guidance on Lenacapavir Sodium→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021730 - Draft Guidance on Levalbuterol Tartrate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_008816 - Draft Guidance on Lidocaine Hydrochloride→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_021850 - Draft Guidance on Magnesium Hydroxide; Omeprazole; Sodium Bicarbonate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_019962 - Draft Guidance on Metoprolol Succinate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_219373 - Draft Guidance on Metoprolol Tartrate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_017963 - Draft Guidance on Metoprolol Tartrate→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_219379 - Draft Guidance on Mirdametinib→
Closed on Jul 22, 2026
Other· May 22, 2026
PSG_205641 - Draft Guidance on Mometasone Furoate→
Closed on Jul 22, 2026