Remove 2025 Remove Court Rules Remove Statute
article thumbnail

Oops!… [FDA] Did It Again: Another Orphan Drug Act Loss for FDA Based on Unambiguous Statutory Text; 11th Circuit Rules that the Scope of Orphan Drug Exclusivity is Determined by the Rare Disease or Condition Designated, and Not the Indication Approved

FDA Law Blog

In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute. As courts keep hitting the Agency “…Baby, One More Time ,” the appellate court these days seems Toxic for FDA.

Statute 52
article thumbnail

The drop in straight grants is indeed not permanent — Part I

At the Lectern

The order granting the reconsideration petition was made more than 60 days after the petition’s filing, and the then-governing statute provided a petition “is deemed to have been denied. The Supreme Court directed the appellate court to issue an alternative writ. continuing the trial.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

TikTok at the Supreme Court: First Amendment Meets National Security

Patently O

The order consolidates two emergency applications seeking to block enforcement of the Protecting Americans from Foreign Adversary Controlled Applications Act (PAFACAA) before its January 19, 2025 effective date. That statute would effectively ban TikTok from operating within the US unless it is fully divested from Chinese government control.

Court 52
article thumbnail

Trump asks Supreme Court to delay TikTok ban, will seek “political resolution” upon taking office

JURIST

Instead, he respectfully requests that the Court consider staying the Acts deadline for divestment of January 19, 2025, while it considers the merits of this case. John Sauer, Trumps pick for solicitor general, says President Trump takes no position on the underlying merits of this dispute.

Court 211
article thumbnail

Comparing Recent Federal Circuit Judges

Above The Law

Biden appointed the most judges to the Second Circuit in 2021, to the Ninth in 2022, and even had one judge begin active service in 2025 ( Embry Kidd in the Eleventh Circuit). The issue was whether federal courts can award equitable relief when state law permits it, but an adequate legal remedy exists. 5 Tangreti v.

article thumbnail

February 2021 Updates to the Climate Case Charts

ClimateChange-ClimateLaw

A magistrate judge in the federal district court for the District of Colorado recommended that the court grant an underground coal mine operator’s motion to dismiss a Clean Air Act citizen suit that alleged the mine required a Prevention of Significant Deterioration construction permit and a Title V operating permit. 1:20-cv-01342 (D.

article thumbnail

Circuit Scoop — February 2025

Above The Law

In a series of recent decisions, federal courts across the United States have addressed a range of significant legal issues, from civil rights and constitutional law to administrative authority and criminal justice. Among them are Griffith v. Both sides appealed, leading to a complex legal battle over voting rights and state authority.

Court 69