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Code · REGISTER · 2024-10-31 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Notice of availability

3,078 words·~14 min read·/register/2024/10/31/2024-25391·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidances; Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence
(BE)studies to support abbreviated new drug applications (ANDAs). In the **Federal Register** of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance. DATES: Submit either electronic or written comments on the draft guidance by December 30, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • *Federal eRulemaking Portal:* *https://www.regulations.gov.* Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to *https://www.regulations.gov* will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on *https://www.regulations.gov.* • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows: • *Mail/Hand Delivery/Courier (for written/paper submissions):* Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” *Instructions:* All submissions received must include the Docket No. FDA-2007-D-0369 for “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at *https://www.regulations.gov* or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on *https://www.regulations.gov.* Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: *https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.* *Docket:* For access to the docket to read background documents or the electronic and written/paper comments received, go to *https://www.regulations.gov* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Joseph Kotsybar, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 3623A, Silver Spring, MD 20993-0002, 240-402-1062, *PSG-Questions@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's website at *https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.* As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's website and announced periodically in the **Federal Register** . The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the **Federal Register** . FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the **Federal Register** on August 23, 2024 (89 FR 68162). This notice announces revised draft product-specific guidances that are being posted on FDA's website for a subset of immediate-release oral drug products to reflect FDA's current thinking and to align the bioequivalence recommendations with the recently adopted International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use M13A guideline titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” (October 2024). These revised product-specific guidances recommend that ANDA applicants conduct one bioequivalence study for products with a non-high risk of bioinequivalence due to food effect under either fasting or fed condition rather than conducting two bioequivalence studies: one BE study under fasting conditions, and one BE study under fed conditions. Other revisions, including revisions to align the recommendations in these PSGs with the recently adopted M13A guideline and editorial revisions, are incorporated as appropriate. FDA recommends that applicants consult the relevant product-specific guidance, in conjunction with general guidances on bioequivalence, when considering the design and conduct of studies supporting an evaluation of BE for immediate-release solid oral dosage forms. II. Drug Products for Which Revised Draft Product-Specific Guidances Are Available FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients: Table 1—Revised Draft Product-Specific Guidances for Drug Products Active ingredient(s) Abacavir sulfate Abacavir sulfate; Dolutegravir sodium; Lamivudine (multiple reference listed drugs) Abacavir sulfate; Lamivudine Abacavir sulfate; Lamivudine; Zidovudine Abemaciclib Abrocitinib Acalabrutinib Acetaminophen; Aspirin; Caffeine Acetaminophen; Benzhydrocodone hydrochloride Acetaminophen; Butalbital; Caffeine; Codeine phosphate Acetaminophen; Ibuprofen Acetaminophen; Propoxyphene napsylate Acetaminophen; Tramadol hydrochloride Acetazolamide Acetylcysteine Acrivastine; Pseudoephedrine hydrochloride Acyclovir (multiple reference listed drugs) Adagrasib Adefovir dipivoxil Albuterol sulfate Allopurinol; Lesinurad Almotriptan malate Alogliptin benzoate Alogliptin benzoate; Metformin hydrochloride Alogliptin benzoate; Pioglitazone hydrochloride Alosetron hydrochloride Alprazolam (multiple reference listed drugs) Amantadine hydrochloride (multiple reference listed drugs) Ambrisentan Amifampridine phosphate Amiloride hydrochloride Aminocaproic acid Amiodarone hydrochloride Amitriptyline hydrochloride Amitriptyline hydrochloride; Chlordiazepoxide Amlodipine benzoate Amlodipine besylate Amlodipine besylate; Atorvastatin calcium Amlodipine besylate; Benazepril hydrochloride Amlodipine besylate; Celecoxib Amlodipine besylate; Hydrochlorothiazide; Olmesartan medoxomil Amlodipine besylate; Hydrochlorothiazide; Valsartan Amlodipine besylate; Olmesartan medoxomil Amlodipine besylate; Perindopril arginine Amlodipine besylate; Valsartan Amoxicillin (multiple reference listed drugs) Amoxicillin; Clarithromycin; Vonoprazan fumarate Amoxicillin; Clavulanate potassium (multiple reference listed drugs) Amoxicillin; Vonoprazan fumarate Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine saccharate; Dextroamphetamine sulfate Anagrelide hydrochloride Anastrozole Apixaban Apremilast Aripiprazole (multiple reference listed drugs) Armodafinil Aspirin Aspirin; Butalbital; Caffeine; Codeine phosphate Atazanavir sulfate Atazanavir sulfate; Cobicistat Atenolol Atenolol; Chlorthalidone Atomoxetine hydrochloride Atorvastatin calcium (multiple reference listed drugs) Atorvastatin calcium; Ezetimibe Atovaquone (multiple reference listed drugs) Auranofin Avanafil Avatrombopag maleate Axitinib Azilsartan kamedoxomil Azilsartan kamedoxomil; Chlorthalidone Azithromycin (multiple reference listed drugs) Baclofen (multiple reference listed drugs) Baloxavir marboxil (multiple reference listed drugs) Baricitinib Bedaquiline fumarate Belumosudil mesylate Bempedoic acid Bempedoic acid; Ezetimibe Benazepril hydrochloride Benazepril hydrochloride; Hydrochlorothiazide Benznidazole Berotralstat hydrochloride Bexagliflozin Bicalutamide Binimetinib Bisoprolol fumarate Bisoprolol fumarate; Hydrochlorothiazide Boceprevir Bosentan (multiple reference listed drugs) Bosutinib monohydrate Brexpiprazole Brincidofovir Brivaracetam Bumetanide Bupropion hydrochloride Buspirone hydrochloride Cabotegravir sodium Calcium carbonate; Famotidine; Magnesium hydroxide Canagliflozin Canagliflozin; Metformin hydrochloride Candesartan cilexetil Candesartan cilexetil; Hydrochlorothiazide Capmatinib hydrochloride Carbidopa Carbidopa; Entacapone; Levodopa Carbidopa; Levodopa (multiple reference listed drugs) Carglumic acid Cariprazine hydrochloride Carisoprodol Carvedilol Cefaclor Cefadroxil/cefadroxil hemihydrate Cefdinir (multiple reference listed drugs) Cefditoren pivoxil Cefixime (multiple reference listed drugs) Cefpodoxime proxetil (multiple reference listed drugs) Cefprozil (multiple reference listed drugs) Cefuroxime axetil (multiple reference listed drugs) Celecoxib; Tramadol hydrochloride Cenobamate Cephalexin (multiple reference listed drugs) Ceritinib (multiple reference listed drugs) Cetirizine hydrochloride (multiple reference listed drugs) Cevimeline hydrochloride Chenodiol Chlordiazepoxide hydrochloride Chlordiazepoxide hydrochloride; Clidinium bromide Chlorothiazide Chlorpheniramine maleate; Ibuprofen; Phenylephrine hydrochloride Chlorpheniramine maleate; Ibuprofen; Pseudoephedrine hydrochloride Chlorpromazine hydrochloride Chlorthalidone (multiple reference listed drugs) Chlorzoxazone Cholic acid Cimetidine Cinacalcet hydrochloride Ciprofloxacin Ciprofloxacin hydrochloride Citalopram hydrobromide (multiple reference listed drugs) Clarithromycin (multiple reference listed drugs) Clemastine fumarate (multiple reference listed drugs) Clindamycin hydrochloride Clobazam (multiple reference listed drugs) Clomiphene citrate Clomipramine hydrochloride Clonazepam (multiple reference listed drugs) Clonidine hydrochloride Clopidogrel bisulfate Clorazepate dipotassium Cobicistat Cobimetinib fumarate Colchicine (multiple reference listed drugs) Crizotinib Cyclobenzaprine hydrochloride Cycloserine Daclatasvir dihydrochloride Dacomitinib Dantrolene sodium Dapagliflozin Dapagliflozin; Saxagliptin hydrochloride Daprodustat Dapsone Darolutamide Darunavir (multiple reference listed drugs) Dasatinib Deferiprone Deflazacort (multiple reference listed drugs) Delafloxacin meglumine Delavirdine mesylate Desipramine hydrochloride Desloratadine (multiple reference listed drugs) Desmopressin acetate Desogestrel; Ethinyl estradiol (multiple reference listed drugs) Dexamethasone Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride; Serdexmethylphenidate chloride Dextromethorphan hydrobromide; Quinidine sulfate Diazepam Diazoxide Dichlorphenamide Diclofenac Diclofenac potassium (multiple reference listed drugs) Dicyclomine hydrochloride (multiple reference listed drugs) Dienogest; Estradiol valerate Diflunisal Diphenhydramine citrate; Ibuprofen Diphenhydramine hydrochloride Diphenhydramine hydrochloride; Ibuprofen Diphenhydramine hydrochloride; Naproxen sodium Dipyridamole Disopyramide phosphate Disulfiram Dofetilide Dolasetron mesylate Dolutegravir sodium (multiple reference listed drugs) Dolutegravir sodium; Lamivudine Dolutegravir sodium; Rilpivirine hydrochloride Donepezil hydrochloride (multiple reference listed drugs) Doxazosin mesylate Doxepin hydrochloride (multiple reference listed drugs) Doxycycline (multiple reference listed drugs) Doxycycline calcium Doxycycline hyclate (multiple reference listed drugs) Dronedarone hydrochloride Drospirenone Drospirenone; Estetrol Drospirenone; Estradiol Drospirenone; Ethinyl estradiol (multiple reference listed drugs) Drospirenone; Ethinyl estradiol; Levomefolate calcium Droxidopa Duvelisib Elacestrant dihydrochloride Eletriptan hydrobromide Eliglustat tartrate Eltrombopag olamine (multiple reference listed drugs) Eluxadoline Empagliflozin Empagliflozin; Linagliptin Empagliflozin; Metformin hydrochloride Emtricitabine Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate Emtricitabine; Rilpivirine hydrochloride; Tenofovir disoproxil fumarate Emtricitabine; Tenofovir alafenamide fumarate Emtricitabine; Tenofovir disoproxil fumarate Enalapril maleate Enasidenib mesylate Entacapone Eplerenone Eprosartan mesylate Eprosartan mesylate; Hydrochlorothiazide Erdafitinib Ertugliflozin; Metformin hydrochloride Ertugliflozin; Sitagliptin phosphate Erythromycin ethylsuccinate (multiple reference listed drugs) Erythromycin ethylsuccinate; Sulfisoxazole acetyl Escitalopram oxalate (multiple reference listed drugs) Eslicarbazepine acetate Estradiol Estradiol; Norethindrone acetate Estrogens, esterified Eszopiclone Ethacrynic acid Ethambutol hydrochloride Ethinyl estradiol; Ethynodiol diacetate Ethinyl estradiol; Levonorgestrel (multiple reference listed drugs) Ethinyl estradiol; Norethindrone (multiple reference listed drugs) Ethinyl estradiol; Norethindrone acetate (multiple reference listed drugs) Ethinyl estradiol; Norethindrone acetate; Ethinyl estradiol; Ferrous fumarate Ethinyl estradiol; Norgestimate Ethinyl estradiol; Norgestrel Ethionamide Ethosuximide Etodolac (multiple reference listed drugs) Exemestane Ezetimibe Ezetimibe; Simvastatin Ezogabine Famciclovir Famotidine (multiple reference listed drugs) Famotidine; Ibuprofen Febuxostat Fedratinib hydrochloride Fenofibric acid Fenoprofen calcium Fexofenadine hydrochloride (multiple reference listed drugs) Finasteride Finerenone Fingolimod hydrochloride Fingolimod lauryl sulfate Flavoxate hydrochloride Flecainide acetate Flibanserin Fluconazole Flucytosine Fludrocortisone acetate Fluoxetine hydrochloride (multiple reference listed drugs) Fluoxetine hydrochloride; Olanzapine Fluphenazine hydrochloride Flutamide Fluvastatin sodium Fosamprenavir calcium Fosinopril sodium Fosinopril sodium; Hydrochlorothiazide Frovatriptan succinate Furosemide Futibatinib Gabapentin (multiple reference listed drugs) Galantamine hydrobromide Ganaxolone Ganciclovir Gefitinib Gemifloxacin mesylate Gilteritinib fumarate Glasdegib maleate Glimepiride Glimepiride; Pioglitazone hydrochloride Glimepiride; Rosiglitazone maleate Glipizide Glipizide; Metformin hydrochloride Glyburide (multiple reference listed drugs) Glyburide; Metformin hydrochloride Granisetron hydrochloride Griseofulvin, microcrystalline; Griseofulvin, microsize Guanfacine hydrochloride Haloperidol Hydralazine hydrochloride; Isosorbide dinitrate Hydrochlorothiazide (multiple reference listed drugs) Hydrochlorothiazide; Irbesartan Hydrochlorothiazide; Lisinopril Hydrochlorothiazide; Losartan potassium Hydrochlorothiazide; Metoprolol tartrate Hydrochlorothiazide; Olmesartan medoxomil Hydrochlorothiazide; Quinapril hydrochloride Hydrochlorothiazide; Spironolactone Hydrochlorothiazide; Triamterene (multiple reference listed drugs) Hydrochlorothiazide; Valsartan Hydrocodone bitartrate; Ibuprofen Hydrocortisone Hydromorphone hydrochloride Hydroxychloroquine sulfate Hydroxyzine pamoate (multiple reference listed drugs) Ibrexafungerp citrate Ibrutinib (multiple reference listed drugs) Ibuprofen (multiple reference listed drugs) Ibuprofen sodium Ibuprofen; Phenylephrine hydrochloride Ibuprofen; Pseudoephedrine hydrochloride (multiple reference listed drugs) Icosapent ethyl Idelalisib Iloperidone Imipramine pamoate Indapamide Indinavir sulfate Indomethacin (multiple reference listed drugs) Irbesartan Isavuconazonium sulfate Isocarboxazid Isosorbide dinitrate (multiple reference listed drugs) Isradipine Istradefylline Ivabradine hydrochloride Ketoconazole Ketoprofen Ketorolac tromethamine Lacosamide Lamivudine (multiple reference listed drugs) Lamivudine; Tenofovir disoproxil fumarate (multiple reference listed drugs) Lamivudine; Zidovudine Lamotrigine (multiple reference listed drugs) Larotrectinib sulfate Lasmiditan succinate Leflunomide Lemborexant Lenalidomide Lesinurad Letermovir Letrozole Letrozole; Ribociclib succinate Leucovorin calcium Levetiracetam (multiple reference listed drugs) Levocarnitine Levocetirizine dihydrochloride (multiple reference listed drugs) Levofloxacin Levonorgestrel Levorphanol tartrate Linagliptin Linagliptin; Metformin hydrochloride Linezolid (multiple reference listed drugs) Lisdexamfetamine dimesylate (multiple reference listed drugs) Lisinopril Lofexidine hydrochloride Loperamide hydrochloride (multiple reference listed drugs) Loperamide hydrochloride; Simethicone Loratadine (multiple reference listed drugs) Lorazepam Lumateperone tosylate Lurasidone hydrochloride Lusutrombopag Macitentan Maraviroc Maribavir Mavacamten Mecamylamine hydrochloride Medroxyprogesterone acetate Mefenamic acid Megestrol acetate Meloxicam (multiple reference listed drugs) Memantine hydrochloride Mesna Mestranol; Norethindrone Metformin hydrochloride Metformin hydrochloride; Pioglitazone hydrochloride Metformin hydrochloride; Repaglinide Metformin hydrochloride; Sitagliptin phosphate Methazolamide Methenamine hippurate Methimazole Methoxsalen (multiple reference listed drugs) Methsuximide Methylergonovine maleate Methylphenidate hydrochloride (multiple reference listed drugs) Methylprednisolone Methyltestosterone Metoclopramide hydrochloride (multiple reference listed drugs) Metolazone Metoprolol tartrate Metyrosine Mexiletine hydrochloride Midodrine hydrochloride Miglustat Milnacipran hydrochloride Minocycline hydrochloride (multiple reference listed drugs) Minoxidil Mirtazapine (multiple reference listed drugs) Mitapivat sulfate Mobocertinib succinate Modafinil Molindone hydrochloride Montelukast sodium (multiple reference listed drugs) Morphine sulfate Moxidectin Moxifloxacin hydrochloride Mycophenolate mofetil (multiple reference listed drugs) Nabumetone Nadolol Naldemedine tosylate Naltrexone hydrochloride Naproxen (multiple reference listed drugs) Naproxen sodium (multiple reference listed drugs) Naratriptan hydrochloride Nateglinide Nebivolol hydrochloride Nebivolol hydrochloride; Valsartan Neratinib maleate Netupitant; Palonosetron hydrochloride Nevirapine (multiple reference listed drugs) Nicardipine hydrochloride Nimodipine Nitisinone (multiple reference listed drugs) Nitrofurantoin Nitrofurantoin, macrocrystalline Nitrofurantoin; Nitrofurantoin, macrocrystalline Norethindrone (multiple reference listed drugs) Norethindrone acetate Nortriptyline hydrochloride Obeticholic acid Olanzapine (multiple reference listed drugs) Olanzapine; Samidorphan l-malate Olmesartan medoxomil Omaveloxolone Omega-3-acid ethyl esters type a Ondansetron Ondansetron hydrochloride Oseltamivir phosphate (multiple reference listed drugs) Osilodrostat phosphate Osimertinib mesylate Ospemifene Oteseconazole Oxaprozin Oxazepam Oxcarbazepine (multiple reference listed drugs) Oxybutynin chloride Oxycodone hydrochloride (multiple reference listed drugs) Oxymetholone Ozanimod hydrochloride Pacritinib citrate Palbociclib Palonosetron hydrochloride Panobinostat lactate Paroxetine hydrochloride Paroxetine mesylate (multiple reference listed drugs) Pemigatinib Penbutolol sulfate Penicillin v potassium Perampanel (multiple reference listed drugs) Perindopril erbumine Perphenazine Phenelzine sulfate Phentermine hydrochloride Pilocarpine hydrochloride Pimavanserin tartrate (multiple reference listed drugs) Pimozide Pindolol Pioglitazone hydrochloride Pirfenidone (multiple reference listed drugs) Piroxicam Pitavastatin calcium Pitavastatin magnesium Pitavastatin sodium Pitolisant hydrochloride Pomalidomide Ponesimod Pramipexole dihydrochloride Prasugrel hydrochloride Pravastatin sodium Praziquantel Prazosin hydrochloride Prednisolone Prednisolone acetate Prednisolone sodium phosphate Pregabalin Primaquine phosphate Prochlorperazine maleate Promethazine hydrochloride Propafenone hydrochloride Propranolol hydrochloride Propylthiouracil Protriptyline hydrochloride Prucalopride succinate Pyrazinamide Pyridostigmine bromide Pyrimethamine Quetiapine fumarate Quinapril hydrochloride Raloxifene hydrochloride Ramelteon Ramipril (multiple reference listed drugs) Ranitidine hydrochloride (multiple reference listed drugs) Relugolix Repaglinide Reserpine Ribavirin (multiple reference listed drugs) Ribociclib succinate Rifapentine Rilpivirine hydrochloride Rimegepant sulfate Riociguat Risperidone (multiple reference listed drugs) Rivastigmine tartrate Rizatriptan benzoate (multiple reference listed drugs) Roflumilast Rolapitant hydrochloride Ropinirole hydrochloride Rosiglitazone maleate Rosuvastatin calcium Rufinamide (multiple reference listed drugs) Ruxolitinib phosphate Sacubitril; Valsartan Safinamide mesylate Sapropterin dihydrochloride Sarecycline hydrochloride Saxagliptin hydrochloride Selegiline hydrochloride (multiple reference listed drugs) Selexipag Selpercatinib Sertraline hydrochloride (multiple reference listed drugs) Sibutramine hydrochloride Sildenafil citrate (multiple reference listed drugs) Silodosin Simvastatin (multiple reference listed drugs) Simvastatin; Sitagliptin phosphate Siponimod Sitagliptin phosphate Sodium phenylbutyrate (multiple reference listed drugs) Sodium phenylbutyrate; Taurursodiol Sofosbuvir Solifenacin succinate Solriamfetol hydrochloride Sotalol hydrochloride (multiple reference listed drugs) Sotorasib Sparsentan Spironolactone (multiple reference listed drugs) Stavudine Stiripentol (multiple reference listed drugs) Succimer Sulfadiazine Sulfamethoxazole; Trimethoprim (multiple reference listed drugs) Sumatriptan succinate Tadalafil Tafenoquine succinate (multiple reference listed drugs) Tamoxifen citrate Tapentadol hydrochloride Tasimelteon Tecovirimat Tedizolid phosphate Telbivudine Telithromycin Telotristat etiprate Temazepam Tenofovir alafenamide fumarate Tenofovir disoproxil fumarate (multiple reference listed drugs) Tepotinib hydrochloride Terazosin hydrochloride Terbinafine hydrochloride (multiple reference listed drugs) Terbutaline sulfate Teriflunomide Testosterone undecanoate Tetrabenazine Tetracycline hydrochloride Thioridazine hydrochloride Thiothixene Tiagabine hydrochloride Ticagrelor Ticlopidine hydrochloride Timolol maleate Tivozanib hydrochloride Tizanidine hydrochloride Tofacitinib citrate Tolcapone Tolterodine tartrate Topiramate (multiple reference listed drugs) Toremifene citrate Torsemide (multiple reference listed drugs) Trandolapril Tranylcypromine sulfate Trazodone hydrochloride Triamterene Triazolam Triclabendazole Trimethoprim Trimipramine maleate Ubrogepant Ulipristal acetate Uridine triacetate Ursodiol (multiple reference listed drugs) Valacyclovir hydrochloride Valbenazine tosylate Valganciclovir hydrochloride Valsartan Vandetanib Vardenafil hydrochloride (multiple reference listed drugs) Varenicline tartrate Vericiguat Vibegron Vilazodone hydrochloride Vismodegib Vorapaxar sulfate Vortioxetine hydrobromide Voxelotor (multiple reference listed drugs) Zalcitabine Zaleplon Zidovudine (multiple reference listed drugs) Zileuton Ziprasidone hydrochloride (multiple reference listed drugs) Zolmitriptan (multiple reference listed drugs) Zolpidem tartrate Zonisamide For a complete history of previously published **Federal Register** notices related to product-specific guidances, go to *https://www.regulations.gov* and enter Docket No. FDA-2007-D-0369. These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 While these guidances contain no collection of information, they do refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 312 for investigational new drugs have been approved under 0910-0014. The collections of information in 21 CFR part 314 for applications for FDA approval to market a new drug and in 21 CFR part 320 for bioavailability and bioequivalence requirements have been approved under OMB control number 0910-0001. IV. Electronic Access Persons with access to the internet may obtain the draft guidance at *https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents,* or *https://www.regulations.gov.* Dated: October 24, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024-25391 Filed 10-30-24; 8:45 am]
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  • 44 USC 3501-3521
  • 21 CFR 312
  • 21 CFR 314
  • 21 CFR 320
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cites case law
Rules and Regulations
Notice of availability
C.F.R.§ 10.20
C.F.R.§ 10.115
Cite44 USC 3501-3521
Cite21 CFR 312
Cite21 CFR 314
Cite21 CFR 320
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