Federal Criminal Defense Guides

FDA Warning Letter vs. FDA Form 483: The Difference Can Decide What Happens Next One of the most common questions companies ask after an FDA inspection is this: What is the difference between a Form FDA 483 and an FDA warning letter? The short answer is that a 483 is generally the inspection-stage document, while a […]

Release Pending Appeal in Federal Court By Ronald W. Chapman II Last reviewed: April 2026 Release pending appeal in federal court is possible, but it is difficult. Once a defendant has been convicted and sentenced to imprisonment, the presumption shifts sharply toward detention. Federal law requires more than a promising issue and more than a sympathetic […]

Can You Appeal After a Guilty Plea in Federal Court? By Ronald W. Chapman II Last reviewed: April 2026 Yes, you can sometimes appeal after a guilty plea in federal court. But the appeal is usually narrower, more technical, and more dependent on the exact plea record than clients expect. A guilty plea generally gives up […]

Appeal Waivers in Federal Plea Agreements By Ronald W. Chapman II Last reviewed: April 2026 An appeal waiver in a federal plea agreement is powerful, but it is not magic. It can narrow appellate options dramatically, but it does not answer every question by itself. The exact wording matters. The Rule 11 hearing matters. The sentence […]

Petition for Rehearing and Rehearing En Banc in a Federal Criminal Appeal By Ronald W. Chapman II Last reviewed: April 2026 Losing a federal criminal appeal does not always mean the next move is over. In some cases, the right response is a petition for panel rehearing, rehearing en banc, or both. But those petitions are not routine […]

Supreme Court Review After a Federal Criminal Appeal By Ronald W. Chapman II Last reviewed: April 2026 After a federal criminal appeal is denied, some cases are candidates for Supreme Court review. Most are not. The Supreme Court does not function as a general error-correction court for every adverse circuit decision. Review is discretionary, and the […]

What Happens After a Federal Criminal Appeal Is Denied? By Ronald W. Chapman II Last reviewed: April 2026 A denied federal criminal appeal is not always the end of the case, but it is a major decision point. The next step may be panel rehearing, rehearing en banc, a petition for writ of certiorari, a motion […]

 FDA Authority vs. Medical Practice Executive Summary: In drafting this article, I find that FDA authority over peptides centers on their status as drugs/biologics – the FDA regulates their manufacturing, importation, and distribution, but not the practice of medicine (i.e. a physician’s decision to prescribe or administer). As FDA guidance and statute make clear, FDA’s […]

A major federal appellate decision may significantly change how the Drug Enforcement Administration (DEA) prosecutes pharmacies for controlled-substance violations. In Neumann’s Pharmacy, LLC v. DEA, the U.S. Court of Appeals for the Fifth Circuit rejected the DEA’s long-standing interpretation of two key Controlled Substances Act regulations governing pharmacists: 21 C.F.R. §1306.04(a) — the pharmacist’s “corresponding […]

Criminal Prosecution Under the Federal Food, Drug, and Cosmetic Act (FDCA) Federal criminal prosecutions for FDA adulteration and misbranding charges have become one of the most aggressive—and least understood—frontiers of modern white-collar enforcement. Conduct that was once addressed through inspections, warning letters, or civil remedies is now increasingly charged as felony crime, placing physicians, clinic […]