animal-drugs

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TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's AddressRule2017-1960209/18/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and … The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address and to make technical amendments to improve the accuracy of the regulations.new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsors-addressFR-Doc-2017-19602
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of SponsorshipRule2017-0936405/10/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January … The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations.new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drugFR-Doc-2017-09364
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's NameRule2017-0393003/01/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November … The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the change of sponsorship of an application and a change of a sponsor's name.new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-a-new-animalFR-Doc-2017-03930
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's AddressRule2017-0367702/24/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during Septembe … The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor's address.new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-a-new-animalFR-Doc-2017-03677
New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug ApplicationsRule2017-0359602/24/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketi … The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.new-animal-drugs-for-use-in-animal-feed-approval-of-new-animal-drug-applications-withdrawal-ofFR-Doc-2017-03596
Oral Dosage Form New Animal Drugs; Approval of New Animal Drug ApplicationsRule2016-3108412/27/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) f … The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.oral-dosage-form-new-animal-drugs-approval-of-new-animal-drug-applicationsFR-Doc-2016-31084
New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug ApplicationsRule2016-3108312/27/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) f … The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.new-animal-drugs-for-use-in-animal-feed-approval-of-new-animal-drug-applications-withdrawal-ofFR-Doc-2016-31083
New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in FoodProposed Rule2016-2604310/28/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled ``New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.'' The document proposed to revise the animal drug re … The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled ``New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.'' The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.new-animal-drugs-updating-tolerances-for-residues-of-new-animal-drugs-in-foodFR-Doc-2016-26043
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's AddressRule2016-2323009/30/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and … The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsors-addressFR-Doc-2016-23230
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and SulfamethazineRule2016-2198509/14/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated art … The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2- way, fixed-ratio, combination drug product without penicillin.new-animal-drugs-for-use-in-animal-feeds-chlortetracycline-and-sulfamethazine-chlortetracyclineFR-Doc-2016-21985
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal DrugsRule2016-2047108/31/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishm … The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.requirements-for-foreign-and-domestic-establishment-registration-and-listing-for-human-drugsFR-Doc-2016-20471
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's AddressRule2016-1991408/29/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May an … The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications, changes of sponsors' names and addresses, and the voluntary withdrawals of approval of applications.new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drugFR-Doc-2016-19914
New Animal Drugs for Use in Animal Feed; Category DefinitionsRule2016-2014808/24/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved u … The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.new-animal-drugs-for-use-in-animal-feed-category-definitionsFR-Doc-2016-20148
Disqualification of a Clinical InvestigatorProposed Rule2016-1987608/24/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical … The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.disqualification-of-a-clinical-investigatorFR-Doc-2016-19876
New Animal Drugs for Use in Animal Feed; Category DefinitionsProposed Rule2016-2014908/24/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on app … The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.new-animal-drugs-for-use-in-animal-feed-category-definitionsFR-Doc-2016-20149
New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; CorrectionRule2016-1880908/11/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is ta … The Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations.new-animal-drug-applications-contents-of-notice-of-opportunity-for-a-hearing-correctionFR-Doc-2016-18809
New Animal Drugs; Change of SponsorRule2016-1750107/26/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from E … The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.new-animal-drugs-change-of-sponsorFR-Doc-2016-17501
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of SponsorshipRule2016-1351706/08/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and … The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drugFR-Doc-2016-13517
Antimicrobial Animal Drug Sales and Distribution ReportingRule2016-1108205/11/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual … The Food and Drug Administration (FDA or we) is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to us on the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This final rule codifies the reporting requirements established in section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA). The final rule also includes an additional reporting provision intended to enhance our understanding of antimicrobial new animal drug sales intended for use in specific food- producing animal species and the relationship between such sales and antimicrobial resistance.antimicrobial-animal-drug-sales-and-distribution-reportingFR-Doc-2016-11082
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; CorrectionRule2016-0986504/28/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) published a document in the Federal Register of April 18, 2016 (81 FR 22520), amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) … The Food and Drug Administration (FDA) published a document in the Federal Register of April 18, 2016 (81 FR 22520), amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. That rule included two amendatory instructions that cited incorrect sections of 21 CFR part 524.new-animal-drugs-approval-of-new-animal-drug-applications-changes-of-sponsorship-correctionFR-Doc-2016-09865
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