News & Analysis as of

Animal Drugs Federal Food Drug and Cosmetic Act (FFDCA)

Alston & Bird

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Alston & Bird on

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

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

K&L Gates LLP on

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

Husch Blackwell LLP

FDA Issues Warning Letters to Companies Whose Products Are Intended for Use with Food-Producing Animals

Husch Blackwell LLP on

On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued Warning Letters to four companies concerning the illegal sale of unapproved animal drugs containing cannabidiol (CBD) intended for use in food-producing...more

Quarles & Brady LLP

FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances

Quarles & Brady LLP on

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

BCLP

It’s Getting Hot in Here: FDA Clears Food Products from Gene-Edited Heat Tolerant Beef Cattle

BCLP on

On March 7, 2022, the U.S. Food and Drug Administration (“FDA”) announced its “low-risk determination” to clear the marketing of food products derived from beef cattle that have been genetically altered to be more tolerant of...more

Fox Rothschild LLP

California Proposes Regulations Governing Compounding In A Veterinary Premises

Fox Rothschild LLP on

The California Veterinary Medical Board has proposed amending the California Code of Regulations to clarify the process for veterinarians to compound drugs in a veterinary office for the treatment of an animal patient. As...more

McDermott Will & Emery

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

McDermott Will & Emery on

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

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

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

Epstein Becker & Green

FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding

Epstein Becker & Green on

On May 18, 2015, the U.S. Food and Drug Administration (“FDA”) withdrew its 2003 Compliance Policy Guide – Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding...more

BakerHostetler

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

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