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Compliance Regulations and Guidance Affecting your Industry
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Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
On Demand Access Anytime
By - Christopher W. Olmsted
On Demand Access Anytime
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How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime
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Substances Prohibited From Use in Animal Food or Feed; Confirmation of Effective Date of Final ....
- Industry: Food Safety Compliance
The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ‘‘Substances Prohibited From Use in Animal Food or Feed.’’ In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ‘‘Background’’ section. This document corrects that error.
Beverages: Bottled Water Regulation
- Industry: Food Safety Compliance
The Food and Drug Administration (FDA) is amending its bottled water regulations to require that bottled watermanufacturers test source water for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is amending its bottled water regulations to require, if any coliform organisms are detected in finished bottled water products, that bottled water manufacturers determine whether any of the coliform organisms are E. coli. FDA also is amending the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. Bottled water containing E. coli will be considered adulterated, and source water containing E. coli will not be considered to be of a safe, sanitary quality and will be prohibited from use in the production of bottled water. FDA is also amending its bottled water regulations to require that, before a bottler can use source water from a source that has tested positive for E. coli, the bottler must take appropriate measures to rectify or eliminate the cause of E. coli contamination of that source, and that the bottler must keep records of such actions. Existing regulatory provisionsrequire bottled water manufacturers to keep records of new testing required by this rule. This final rule will ensure that FDA’s standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by the Environmental Protection Agency (EPA) for public drinking water.
Effective Date: This rule is effective December 1,2009
Beverages: Bottled Water; Correction
- Industry: Food Safety Compliance
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Friday, May 29, 2009 (74 FR 25651). The final rule was published with an inadvertent error in the ‘‘Analysis of Impacts’’ section. This document corrects that error
Advisory Committee; Risk Communication Advisory Committee;Termination and Recharter
- Industry: Drugs and Chemicals (Pharma)
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.
Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment
- Industry: Food Safety Compliance
The Food and Drug Administration (FDA) is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. These actions are needed to implement the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents requesting nominations for voting and non-voting membership on this committee. This document also amends the agency’s regulations to add the Tobacco Products Scientific Advisory Committee (the committee) to the agency’s list of standing advisory committees.
Effective Date: This rule is effective August 26, 2009
Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac
- Industry: Drugs and Chemicals (Pharma)
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
New Animal Drugs; Fomepizole
- Industry: Drugs and Chemicals (Pharma)
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; Availabili ....
- Industry: Drugs and Chemicals (Pharma)
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.
Enforcement of General Tobacco Standard Special Rule for Cigarettes
- Industry: Food Safety Compliance
The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that as of the effective date identified in the FSPTCA, cigarettes that contain certain characterizing flavors are considered adulterated under the act. FDA is also providing in this notice contact information to which individuals who observe violative products after the effective date of the tobacco standard special rule may report their observations to FDA.
Implantation or Injectable Dosage Form New Animal Drugs; Change ofSponsor; Luprostiol.
- Industry: Drugs and Chemicals (Pharma)
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
Oral Dosage Form New Animal Drugs;Methimazole
- Industry: Drugs and Chemicals (Pharma)
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
Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic An ....
- Industry: Drugs and Chemicals (Pharma)
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.
Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Dru ....
- Industry: Drugs and Chemicals (Pharma)
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 .
Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeepin ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for 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 serious adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by FDA’s Center for Drug Evaluation and Research, on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.
New Animal Drugs for Use in Animal Feeds; Chlortetracycline
- Industry: Drugs and Chemicals (Pharma)
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 Alpharma Inc. The supplemental NADA provides for revised Blue Bird labeling for chlortetracycline Type A medicated articles used to formulate Type B and Type C medicated feeds in various classes of livestock and poultry.
Effective Date:This rule is effective June 12,2009
Oral Dosage Form New Animal Drugs;Toceranib
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of toceranib phosphate tablets in dogs for treatment of recurrent, cutaneous mast cell tumors .
Effective Date: This rule is effective June 18,2009
Oral Dosage Form New Animal Drugs;Trilostane
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the supplemental approval of a new animal drug application (NADA) filed by Dechra, Ltd. The supplemental NADA provides for the addition of a 10- milligram capsule size of trilostane, used in dogs for treatment of hyperadrenocorticism.
Effective Date: This rule is effective June 26,2009.
New Animal Drugs; Ceftiofur Sodium
- Industry: Drugs and Chemicals (Pharma)
The Food and DrugAdministration (FDA) is amending theanimal drug regulations to reflectapproval of an original abbreviated newanimal drug application (ANADA) filedby Cephazone Pharma, LLC. TheANADA provides for the use of ceftiofursodium powder for injection as asolution in dogs, horses, cattle, swine,day old chickens, turkey poults, sheep,and goats as therapy for variousbacterial infections.
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of flunixin meglumine injectable solution in swine.
Effective Date: This rule is effective July 15, 2009
Implantation or Injectable Dosage Form New Animal Drugs - Flunixin
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of flunixin meglumine injectable solution in swine.
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