Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal drugs for use in aquarium fish and...more
This update is the final in a multi-part series exploring FDA approval of pet care drugs. In part one of our series we discussed that before an animal drug product can be legally marketed for use in animals, a New Animal Drug...more
The wait is finally over. On April 14, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk...more
In this webinar, we’ll discuss what we know about FDA regulation of cannabis and cannabis-derived products and look at trends in recent FDA enforcement over CBD products. Topics include: - Pathways for FDA...more
As a veterinarian, if a pet-owner comes to you with questions or concerns about the safety of hemp or CBD infused pet products, are you prepared to navigate the conversation? Practicing veterinarians are subject to the...more
Food - FDA Is Investigating an Outbreak of Cyclospora in Bagged Salads – The FDA is investigating a multistate outbreak of cyclospora infections potentially linked to salad products....more
The business of animal health has traditionally been dominated by the animal health divisions of big pharma companies. But with Pfizer’s 2013 spin-off of its animal health business, now known as Zoetis, the sector has been...more
Food/Dietary Supplements - FDA Investigates Multiple Foodborne Illness Outbreaks – The FDA and the CDC have launched a multistate investigation of a Salmonella Concord outbreak linked to certain tahini products. ...more
On 19 June 2018, the European Medicines Agency (EMA) published updates to its Brexit Q&A document for human and veterinary medicines authorised via the centralised procedure and to its practical procedural guidance on making...more
On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more
Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more