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Food and Drug Administration (FDA) › Oral Argument

ArentFox Schiff

Four Months Out: Private Fund Advisors Prepare for September Compliance Deadline Amidst Challenge in the Fifth Circuit

ArentFox Schiff on

In September 2023, we covered the Rules (Rule) published by the US Securities and Exchange Commission (SEC), developed to promote transparency for investors by increasing visibility into compensation schemes, sales practices,...more

Foley Hoag LLP

Oral Arguments in FDA v. Alliance for Hippocratic Medicine: Mifepristone Case Likely to Turn on Article III Standing Requirements

Foley Hoag LLP on

Nearly two years after the Court overturned Roe v. Wade in June 2022, additional challenges are being brought that may limit access to abortion in the U.S. Mifepristone was originally approved in 2000 by the U.S. Food and...more

Axinn, Veltrop & Harkrider LLP

Ready for the Flood of Litigation Against Federal Agencies?

Axinn, Veltrop & Harkrider LLP on

Yesterday, the Supreme Court heard oral arguments in two related cases that may have a significant impact on litigation against federal agencies – Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce....more

Akin Gump Strauss Hauer & Feld LLP

District Court Affirms FDA Policy on Compounding with Bulk Drug Substances—Bringing Much Needed Clarity for the Outsourcing...

Akin Gump Strauss Hauer & Feld LLP on

On August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration’s (FDA’s) decision to exclude the bulk drug substance vasopressin from the agency’s List of Bulk Drug...more

Goodwin

Reminder: Supreme Court Arguments on April 26th in Amgen v. Sandoz

Goodwin on

As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions: ..Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Preview -- Sandoz Inc. v. Amgen Inc. -- 180 Day Notice of Commercial Marketing Provisions of BPCIA

McDonnell Boehnen Hulbert & Berghoff LLP on

On Wednesday, April 26, the Supreme Court will hear oral arguments in Sandoz Inc. v. Amgen Inc, involving interpretation for the first time of the Biologics Price Competition and Innovation Act ("BPCIA"), which was enacted...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Oral Arguments in Amgen v. Sandoz

Patterson Belknap Webb & Tyler LLP on

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Act II: Oral Argument in Amgen v. Sandoz is heard at the Court of Appeals for the Federal Circuit

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument...more

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