2018 CVM Updates

December

• December 18, 2018 - FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2017 for Use in Food-Producing Animals Showing Declines for Past Two Years
• December 13, 2018 - FDA Works to Keep Injectable Opioids Available to Treat Animals’ Surgical and Trauma Pain During Ongoing Supply Shortage
• December 6, 2018 - FDA Working with Stakeholders to Maintain Effectiveness of Livestock and Horse Dewormers
• December 4, 2018 - FDA Approves Pexion for Treating Noise Aversion in Dogs

November

• November 28, 2018 - FDA Adds Resources to Assist Food Facilities with This Year’s Biennial Registration Renewal
• November 26, 2018 - FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species
• November 16, 2018 - FDA Proposes Study with Intent of Eliminating Use of Dogs in Certain Types of Research
• November 13, 2018 - Registration Reminder: FDA Center for Veterinary Medicine Public Webinar about Genome Editing in Animals on Dec. 3
• November 13, 2018 - Updated - FDA Publishes Design Recommendations for Residue Studies in Honey
• November 6, 2018 - FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste
• November 5, 2018 - FDA Finalizes Guidance on Mandatory Recall Authority

October

• October 30, 2018 - FDA Announces Plant and Animal Biotechnology Innovation Action Plan
• October 17, 2018 - FDA Warns Two Firms about Monensin Contamination in Horse Feed
• Updated October 12, 2018 - Resources for Animal Food Producers in Flooded Areas of Gulf Coast
• October 1, 2018 - FY 2016 Pesticide Analysis Demonstrates Consistent Trends Over Five Years

September

• September 25, 2018 - FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA
• September 24, 2018 - FDA Announces Availability of Resources for Animal Drug Sponsors
• September 21, 2018 - FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats
• September 20, 2018 - Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products
• September 19, 2018 - FDA Opening VQIP Application Portal October 1
• September 14, 2018 - FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings
• September 14, 2018 - FDA Releases Information for Qualified Facilities under Preventive Controls Rules
• September 13, 2018 - Resources for Animal Food Producers in Flooded Areas
• September 10, 2018 - FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series

August

• August 17, 2018 - Animal Drug User Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications
• August 17, 2018 - FDA Issues Guidance Documents on Food Facility Registration
• August 17, 2018 - The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs - updated
• August 14, 2018 - What’s Next For PC Animal Food Implementation?
• August 07, 2018 - FDA’s Center for Veterinary Medicine Announces Second eSubmitter Webinar in Ongoing Series

July

• July 24, 2018 - FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease
• July 23, 2018 - FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species
• July 18, 2018 - FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs
• July 12, 2018 - FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease
• July 10, 2018 - FDA announces Ranier’s Rx Laboratory’s voluntary recall of all sterile compounded drug
• July 03, 2018 - FDA Animal Drug Safety Communication: FDA highlights potential health risks to people exposed to altrenogest products for horses or pigs

June

• June 29, 2018 - UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo
• June 28, 2018 - FDA Releases Guidance to Help Animal Drug Sponsors with Antimicrobial Animal Drug Sales and Distribution Reporting Requirements
• June 14, 2018 - FDA Releases FSMA Draft Guidance on the Supply-Chain Program Preventive Control for Animal Food

May

• May 25, 2018 - With VQIP Application Period set to Expire, FDA Encourages Importers to Prepare Early for Next Cycle
• May 25, 2018 - New Guide Helps Small Food Facilities Register with FDA
• May 24, 2018 - FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats
• May 23, 2018, updated August 17, 2018 - The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs
• May 16, 2018 - FDA Expands Data Dashboard to Include FSMA
• May 14, 2018 - FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats
• May 03, 2018 - CVM eSubmitter Webinar 1 Agenda

April

• April 26, 2018 - FDA Approves Application for AquaBounty Salmon Facility in Indiana
• April 26, 2018 - FDA Issues Guidance on the Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species # 210
• April 03, 2018 - CVM releases eSubmitter Webinar Series

March

• March 09, 2018 - FDA Issues Guidance on Proprietary Names for New Animal Drugs

February

• February 13, 2018 - FDA Proposes to Require Electronic Submission of Certain Postmarketing Safety Reports for Approved New Animal Drugs

January

• January 31, 2018 - FDA Takes Important New Steps to Strengthen Oversight of Food Imports
• January 24, 2018 - FDA Issues Guidance Documents to help Importers and Food Producers meet FSMA Requirements
• January 22, 2018 - FDA Releases FSMA Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Animal Food
• January 04, 2018 - FDA Announces Enforcement Discretion Policy for Certain FSMA Regulations