Nearly five years after the passage of the Animal Drug User Fee Amendments Act (ADUFA) of 2008, the US Food and Drug Administration (FDA) is proposing to expand upon its data reporting requirements, saying companies will need to include even more data on the antimicrobial drugs they sell for use in food-producing animals. Background The policy is being advanced through proposed rulemaking released on 26 September 2013 by the agency. It was first released as a propose...

US President Barack Obama has signed into law a new piece of legislation that is set to increase the amount of funding given to the US Food and Drug Administration (FDA) by the veterinary pharmaceutical industry in the hopes of speeding up review and clearance times for product applications. Background The legislation, known as the  Animal Drug and Animal Generic Drug User Fee Reauthorization Act (ADAGDUFRA) , is an amalgamation of the Animal Drug User Fee A...

US legislators in the House of Representatives this week announced the passage of a package of user fees that would enhance what the US Food and Drug Administration (FDA) collects from members of the veterinary pharmaceutical industry. Background Passage of the legislation was in many ways overshadowed by the debate over and passage of another major piece of legislation that would reform security standards for the pharmaceutical industry, known as the Safeguarding Am...

With the steady drumbeat of Form 483s, Warning Letters and Untitled Letters sent by the US Food and Drug Administration (FDA) to pharmaceutical, medical device and dietary supplement manufacturers, it can be difficult to remember that those aren't the only life science industries FDA regulates-a fact that was brought into clear view last week when the agency sent a New Kersey-based veterinary pharmaceutical company an Advisory Action Letter. Rare Letter, Common Problems ...

US legislators on the House of Representatives' Energy and Commerce Committee have finally released the draft versions of two bills that would serve to reauthorize industry-paid user fees for both innovative and generic veterinary medicines. Background The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) , are, like their human prescription drug and medical device counterparts, a mechanism by which the veterinary pharmace...

The US Food and Drug Administration (FDA) has announced guidance documents its Center for Veterinary Medicines (CVM) plans to publish by the end of the 2013 calendar year, including several topics that could be harbingers for the rest of the pharmaceutical industry. The publication of the guidance list follows similar publications of documents for medical device and pharmaceutical products , and includes a number of important guidance documents. Of note: Draft Guida...

Congress has begun the process of taking up two bills that stand to make reforms to the user fee process for innovative and generic veterinary pharmaceutical products with the stated goals of generating faster approval times for products while providing better funding sources for the US Food and Drug Administration (FDA). Background The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) , are similar in nature to an omnibus ...

The European Medicines Agency (EMA) has released a new concept paper on the need for a new guideline to better quantify and control the risks of antimicrobial resistance stemming from veterinary antimicrobial products. Antimicrobial Resistance The concept paper, for a guideline on microbial resistance risk assessment , makes the case that antimicrobial resistance (AMR) is an increasingly important problem for both regulators and public health officials, and that...

A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility. The company, Performance Products Inc (PPI), was accused of "significant deviations of Current Good Manufacturing Practice (CGMP) regulations" in the 20 November 2012 letter. PPI manufactures a number of products aimed at bovine and equine species, with most of those products being probiotic in nature. The company's website boats about it...

Animal drug products may not be expected to meet the same standards for safety and efficacy as their human-intended counterparts, but that doesn't mean that their eventual recipients don't appreciate a product that's easy on both their taste buds and sense of smell. That's the finding of a new draft guideline out from the European Medicines Agency (EMA), On the Demonstration of Palatability of Veterinary Medicinal Products , which lays out the requirements for veter...

The Federal Trade Commission (FTC) has released the draft agenda for an upcoming meeting that could shake up the veterinary pharmaceutical sector. The meeting, "Competition & Consumer Protection Issues in the Pet Medications Industry," was first announced in June 2012, and was called in response to FTC's perception that consumer-focused veterinary medications were subject to anti-competitive pricing and access issues. "American consumers spend a tremendous amount ...

The US Food and Drug Administration (FDA) has announced the release of a new draft compliance policy guide (CPG) regarding the labeling and marketing of veterinary food products intended for use in canine and feline species. The CPG is intended to broadcast the agency's anticipated use of its enforcement discretion for products that are specifically intended to diagnose, treat, cure or prevent disease in the two species. FDA said its Center for Veterinary Medicine (CVM) ...