Compliance Regulations and Guidance Affecting your Industry

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.

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

 

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

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.

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.

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
 

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.
 

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.

Effective Date :This rule is effective August 3, 2009

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.

The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug  application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking  this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA).  FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and  that the agency update the list quarterly.