Thursday, September 29, 2016
The Law of Compounding Medications And Drugs: Veterinary-drugs peddler eludes justice Sean Gerso...: http://news.vin.com/VINNews.aspx?articleId=41978
Informational Webinar on FSMA Draft Guidances for Current Good Manufacturing Practices Requirements for Food for Animals and the Human Food By-Products for Use as Animal Food September 29, 2016
Informational Webinar on FSMA Draft Guidances for Current Good Manufacturing Practices Requirements for Food for Animals and the Human Food By-Products for Use as Animal Food
On webinar to discuss FDA’s recent announcement of the FSMA draft guidances for current good manufacturing practices requirements for food for animals and thehuman food by-products for use as animal food, which became available for public comment on August 25, 2016. These draft guidances are meant to assist domestic and foreign companies in complying with Current Good Manufacturing Practice (cGMP) requirements and with human food by-product requirements under the FSMA Preventive Controls for Animal Food Rule., the FDA Foods and Veterinary Program will hold a
Monday, September 26, 2016
Thursday, September 22, 2016
United States: AMS Implements The Livestock Mandatory Reporting Program
In the August 11, 2016, Federal Register, USDA's AMS implemented the Livestock Mandatory Reporting ("LMR") program as required by the Livestock Mandatory Reporting Act of 1999.
Wednesday, September 21, 2016
The U.S. Food and Drug Administration has issued final guidance for industry (GFI #233) entitled, “Veterinary Feed Directive Common Format Questions and Answers” to provide animal drug sponsors who are seeking approval for use of their drug in or on animal feed as a veterinary feed directive (VFD) drug with a recommended common format for a fillable form -- called a VFD -- that can later be used by veterinarians to authorize the use of the sponsor’s drug in feed.
Saturday, September 17, 2016
Thursday, September 15, 2016
Draft Revised Guidance for Industry #171 - Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
This draft revised guidance document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for submitting data demonstrating the bioequivalence of animal drugs in soluble powder oral dosage form products and Type A medicated articles. It expands upon CVM’s Bioequivalence Guidance, particularly the section on Criteria for Waiver of In Vivo Bioequivalence Study.
This guidance is applicable to generic investigational new animal drug (JINAD) files and abbreviated new animal drug applications (ANADAs). Although the recommendations in this guidance reference generic drug applications, the general principles described may also be applicable to new animal drug applications (NADAs), investigational new animal drug (INAD) files, and supplemental NADAs.
Monday, September 12, 2016
FDA Seeks Public Input on Next Steps to Help Ensure Judicious Use of Antimicrobials in Animal Agriculture
The U.S. Food and Drug Administration announced today it is entering the next phase of its efforts to mitigate antimicrobial resistance by focusing for the first time on medically important antimicrobials (i.e., those important for treating human disease) used in animal feed or water that have at least one therapeutic indication without a defined duration of use.
Sunday, September 11, 2016
The Law of Compounding Medications And Drugs: The Friday Show Presented By Woodbine: A Gaping Ho...: http://www.paulickreport.com/features/the-friday-show/a-gaping-hole-in-drug-testing/
Friday, September 9, 2016
Thursday, September 8, 2016
Saturday, September 3, 2016
Columbia Daily Tribune-15 hours ago
Missouri gets its execution drug from a compounding pharmacy that corrections officials refuse to name, with similar intense secrecy cloaking whether the drug is