On April 13, 2022, FDA released its long-anticipated final Guidance for Industry # 256 – Compounding Animal Drugs from Bulk Drug Substances (GFI). As readers of this blog likely remember, the animal drug compounding GFI has had a relatively long and tortured history, blogged about …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Jeffrey Shapiro and Serra Schlanger will present at this year’s Food and Drug Law Institute virtual Advertising and Promotion for Medical Products Conference on October 13–15. This conference will analyze the latest regulatory issues related …
Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to …
FDA recently released its latest revised draft guidance addressing compounding of animal drug products from bulk substances. This iteration is not only a re-do of the draft guidance that FDA released in 2015 (blogged about here), but it also includes some new concepts such as …
On September 30, 2019, FDA announced the availability of a draft guidance for Industry, titled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.” This guidance addresses a special pathway for approval of animal drugs that address serious or life-threatening diseases or conditions, or …
On Dec. 18, 2018, the Center of Veterinary Medicine (CVM) of FDA announced the publication of its 2017 Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. This report is required by the Animal Drug User Fee Amendments of 2008. Under that law, …
To the possible chagrin of those who think that FDA lacks jurisdiction over gene-editing of plants and animals, the Agency announced a Plant and Animal Biotechnology Innovation Action Plan that lays out actions the Agency is taking to help harness the potential benefits of the …
On Sept. 10, 2018, the Food Safety Inspection Service (FSIS) of the USDA and FDA announced a joint public hearing scheduled for Oct. 23-24, 2018. The federal register announcement, explains that this will follow a meeting by FDA’s Science Advisory Board on October 22, 2018. The …
On August 17, FDA announced that the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 had been signed into law. As the name of the law suggests, it reauthorizes the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User …
On Monday, January 21 (amid the government shutdown) the Center for Veterinary Medicine of the Food and Drug Administration (CVM) released a draft guidance document addressing Subpart C of the Agency’s regulation titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food …
In likely the first time since the United States Court of Appeals for the Fifth Circuit decided Medical Center Pharmacy v. Mukasey, 536 F.3d 385 (5th Cir. 2008) (see our previous post here), a federal court located in the Western District of Louisiana (within the …
Cue up “For The Love of Money” by The O’Jays (and theme song of The Apprentice) . . . The Trump Administration’s Fiscal Year 2018 Budget Proposal is out! On May 23, 2017, The White House Office of Management and Budget released President Trump’s Fiscal Year …
It has been 40 years since Steve Perry changed the lyrics to the iconic song Lights to refer to San Francisco rather than Los Angeles. As it turns out, litigants looking to gain easy access to otherwise confidential agency documents may want to make the …
As we reported previously, just before President Trump took the oath of office, FDA issued two guidance documents regarding its approach to the regulation of genetically engineered (“GE”) animals. One of those guidance documents was a revision of a 2009 guidance document that, for the first …
Just before President Trump took office, FDA issued a series of documents detailing how it would regulate the products of gene editing. Specifically, FDA issued policy statements in the form of an announcement on its website and an article in the FDA Voice, FDA’s official …
