Compliance Regulations and Guidance Affecting your Industry

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. The supplemental NADA provides for the use of fixedcombination Type A medicated articles containing oxytetracycline and neomycin sulfate to formulate two-way, fixed-combination drug Type B and Type C medicated feeds for chickens, turkeys, swine, cattle, and sheep. This approval reflects FDA’s effectiveness conclusions which relied on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group’s evaluation of the effectiveness of these drugs when used in animal feed as single ingredients

Effective Date: This rule is effective August 13, 2009

The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediatesize patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Phibro Animal Health. The NADA provides for use of single-ingredient Type A medicated articles containing semduramyicin (as semduramicin sodium biomass) and virginiamycin to manufacture 2-way combination drug Type C medicated feeds for use in broiler chickens .

Effective Date: This rule is effective August 18,2009

The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of ‘‘minor use’’ that relied on the phrase ‘‘small number of animals’’ to characterize such use. At this time, the Food and Drug Administration (FDA) is amending the implementing regulations of the MUMS Act. In response to Congress’ charge to the agency to further define minor use, this amendment establishes a specific ‘‘small number of animals’’ for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use

Effective Date: This rule is effective November 9, 2009

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.’’ The document provides guidance to the dietary supplement industry for complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate guidance on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, issued by FDA’s Center for Drug Evaluation and Research, is announced elsewhere in this issue of the Federal Register

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.’’ This guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate guidance, issued by the Center for Food Safety and Applied Nutrition on complying with the labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘End-of-Phase 2A Meetings.’’ This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo), designing trials for better dose response estimation and dose selection, and other related issues. This guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for sometribove zinc suspension from Monsanto Co. to Elanco Animal Health, A Division of Eli Lilly & Co

Effective Date:This rule is effective October 16,2009

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.’’ This guidance document describes a means by which wound dressing with Poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify wound dressing with pDADMAC additive into class II (special controls). This guidance document is being immediately implemented as the special control for wound dressing with pDADMAC additive, but it remains subject to comment in accordance with the agency’s good guidance practices (GGPs).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and review staff entitled ‘‘Labeling for Human Prescription Drug and Biological Products—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.’’ This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. This guidance finalizes the draft guidance published in the Federal Register on May 16, 2007.

The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to address the development of all types of new animal drug products. This amendment will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. FDA is amending the regulations in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA’s usual procedure for notice-andcomment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and this direct final rule are substantively identical.

Effective Date: This rule is effective March 8,2010

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency’s regulations.

Effective Date: This rule is effective October 29, 2009

The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a discretionary to a statutory committee. This document also amends the agency’s regulations which list advisory committees to reflect that the Risk Communication Advisory Committee has been rechartered and to revise the function statement.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplemental NADA provides for a revised human food safety warning for use of diclofenac sodium topical cream in horses.

Effective Date: This rule is effective September 16, 2009

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA provides for the veterinary prescription use of fomepizole injectable solution as an antidote for ethylene glycol (antifreeze) poisoning in dogs.

Effective Date: This rule is effective September17, 2009.
 

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; AvailabilityThe Food and Drug Administration (FDA) is announcing the  availability of a document entitled  ‘‘Guidance for Industry: Considerations  for Allogeneic Pancreatic Islet Cell  Products’’ dated September 2009. The  guidance document provides  recommendations to manufacturers,  sponsors, and clinical investigators  involved in the transplantation of  allogeneic pancreatic islet cell products  for clinical investigations of the  treatment of type 1 diabetes mellitus.  The guidance identifies the types of data  and information obtained during  investigational new drug studies that  may be helpful in establishing the  safety, purity, and potency of a  biological product in a biologics license  application (BLA). The guidance  announced in this notice finalizes the  draft guidance of the same title, dated  May 2008.


 

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for luprostiol injectable solution from Intervet, Inc., to Virbac AH, Inc.

Effective Date:This rule is effective May 27,2009

The Food and Drug Administration (FDA) is amending theanimal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Dechra,Ltd. The NADA provides for the veterinary prescription use of methimazole tablets in cats fortreatment of hyperthyroidism.

Effective Date: This rule is effective June 11,2009

 

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.’’ The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirementthat FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug productsand make those findings publicly available. This guidance describes how FDA will comply with the FDAAA requirement and procedures forapplication holders to update thelabeling of antibacterial drug products and antimicrobial susceptibility testing (AST) devices.
 

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an ApprovedApplication.’’Thisdocumentprovides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-thecounter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by FDA’s Center for Food Safety and Applied Nutrition on adverse event reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register .