Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2019-03129 · Docket No. FDA-2007-D-0369

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The 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 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Submit either electronic or written comments on the draft guidance by April 26, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 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 November 29, 2018 (83 FR 61388). This notice announces draft product-specific guidances, either new or revised, that are posted on FDA's website. II. Drug Products For Which New Draft Product-Specific Guidances Are Available FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients: Table 1—New Draft Product-Specific Guidances for Drug Products Acalabrutinib. Acetaminophen; Caffeine; Dihydrocodeine bitartrate. Angiotensin II acetate. Bexarotene. Bosentan. Bromocriptine mesylate. Chlorothiazide. Daptomycin. Dexamethasone. Dihydroergotamine mesylate. Diltiazem hydrochloride. Doxycycline calcium. Doxylamine succinate; Pyridoxine hydrochloride. Fish oil; Medium chain triglycerides; Olive oil; Soybean oil. Isocarboxazid. Ivacaftor; Tezacaftor. Letrozole; Ribociclib succinate. Loratadine; Pseudoephedrine sulfate. Methsuximide. Ozenoxacin. Paroxetine mesylate. Succimer. III. 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 2—Revised Draft Product-Specific Guidances for Drug Products Acetaminophen; Butalbital. Aripiprazole. Azelastine HCl; Fluticasone propionate. Betamethasone Dipropionate; Calcipotriene Hydrate (multiple Reference Listed Drugs). Betamethasone Dipropionate; Clotrimazole (multiple Reference Listed Drugs). Butenafine HCl (multiple Reference Listed Drugs). Butoconazole nitrate (multiple Reference Listed Drugs). Calcipotriene (multiple Reference Listed Drugs). Ceritinib. Ciclopirox (multiple Reference Listed Drugs). Clotrimazole (multiple Reference Listed Drugs). Crisaborole. Dexamethasone; Tobramycin (multiple Reference Listed Drugs). Diclofenac sodium. Econazole nitrate. Fluorouracil (multiple Reference Listed Drugs). Fluticasone propionate. Haloperidol. Imiquimod (multiple Reference Listed Drugs). Ingenol mebutate (multiple Reference Listed Drugs). Ketoconazole. Lumacaftor; Ivacaftor. Miconazole. Mometasone furoate monohydrate (multiple Reference Listed Drugs). Oxiconazole Nitrate (multiple Reference Listed Drugs). Tazarotene (multiple Reference Listed Drugs). Terbinafine hydrochloride. Treprostinil diethanolamine (multiple Reference Listed Drugs). Tretinoin. Triamcinolone acetonide. For a complete history of previously published Federal Register documents 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. This guidance is not subject to Executive Order 12866. IV. Electronic Access Persons with access to the internet may obtain the draft guidances at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: February 19, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-03129 Filed 2-22-19; 8:45 am]