FDA Law Blog

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. This all sounds complicated, I know.

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Litigation Litigating Statute Manufacturing 57

Constitutional Law Reporter

SEPTEMBER 8, 2023

Hansen , 599 U.S. _ (2023), the U.S. Supreme Court upheld a federal law that criminalizes “encouraging or inducing” an immigrant to come or remain in the United States unlawfully. According to the Court, the law does not run afoul of the First Amendment. In United States v.

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Immigration Court Statute Construction 52

Constitutional Law Reporter

JUNE 1, 2023

Goertz , 598 U.S. _ (2023), the U.S. Supreme Court held that death row inmate Rodney Reed did not wait too long to seek DNA testing of the evidence in his case. 1983 procedural due process claim begins to run at the end of the state-court litigation. The District Court dismissed Reed’s complaint.

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Statute Litigation Litigating Cause of Action 52

Constitutional Law Reporter

APRIL 4, 2023

United States , 598 U.S. _ (2023), the U.S. Supreme Court held that the penalty for the nonwillful failure to file a Report of Foreign Bank and Financial Accounts (FBAR) is $10,000 per report rather than per account. The statute imposes a maximum $10,000 penalty for nonwillful violations of the law. In Bittner v.

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Court Statute Government Calendaring 59

Constitutional Law Reporter

FEBRUARY 16, 2023

Supreme Court issued its first opinion of the 2022-2023 Term. S. _ (2023), a unanimous Court held that the effective date of an award of service-related disability compensation to a veteran of the United States military determined pursuant to 38 U.S.C. §§ 5110(a)(1) and 5110(b)(1) is not subject to equitable tolling.

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Statute Diligence Court Constitutional Law 52

Constitutional Law Reporter

MAY 1, 2023

United States , 598 U.S. _ (2023), the U.S. Supreme Court held that the Quiet Title Act’s statute of limitations is a claim-processing rule rather than a bright-line rule that constrains a court’s jurisdiction. Justice Sonia Sotomayor wrote on behalf of the Court. In Wilkins v.

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Government Statute Entertainment Constitutional Law 52

Constitutional Law Reporter

APRIL 18, 2023

Sturgis Public Schools , 598 U.S. _ (2023), the U.S. In reaching its decision, the Court noted that the parties offered very different interpretations of §1415( l ). After concluding that §1415( l ) did not preclude Perez’s ADA lawsuit, it remanded the matter back to the lower court. In Perez v.

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Compensatory Damages Education Statute Court 59

At the Lectern

MAY 1, 2024

On Tuesday and Wednesday, May 21 and 22, in San Francisco, the court will hear the following cases (with the issue presented as summarized by court staff or limited by the court itself ): Castellanos v. The court granted review in March 2023. The court granted review in August 2022. Vigilant Insurance Co.

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Calendaring Entertainment Court Statute 45

Constitutional Law Reporter

MAY 10, 2023

Supreme Court has concluded its oral arguments for the 2022-2023 Term. The Court’s final week included four cases, with issues ranging from bankruptcy to RICO to government takings. Below is a brief summary of the issues before the Court: Lac du Flambeau Band of Lake Superior Chippewa Indians v.

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Government Statute Court Legal 59

Constitutional Law Reporter

APRIL 11, 2023

Pennsylvania and Wisconsin , 598 U.S. _ (2023), the U.S. Supreme Court held that uncashed MoneyGram checks are governed by the Disposition of Abandoned Money Orders and Traveler’s Check Act (FDA) and should be returned to the state where they were issued. In Delaware v. It was Justice Ketanji Brown Jackson’s first opinion.

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Constitutional Law Statute Court Government 59

Constitutional Law Reporter

JULY 19, 2023

Colorado , 600 U.S. _ (2023), the U.S. Supreme Court held that to establish that a statement is a “true threat” unprotected by the First Amendment, the state must prove that the defendant had some subjective understanding of the statements’ threatening nature, based on a showing no more demanding than recklessness. In Counterman v.

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Mens Rea Court Constitutional Law Statute 52

SCOTUSBlog

DECEMBER 7, 2022

After a few slow weeks on the relist front, the Supreme Court came roaring back this week with four newly relisted petitions that, if granted, will likely be added to the March 2023 argument calendar. District courts have discretion to impose either consecutive or concurrent sentences unless a statute mandates otherwise.

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Immigration Court Statute Law Firm 94

Constitutional Law Reporter

MARCH 14, 2023

Buckley , 598 U.S. _ (2023), the U.S. Supreme Court held that debts incurred by fraud can’t be discharged in a Chapter 7 bankruptcy, even if a debtor wasn’t culpable for the fraud. Justice Amy Coney Barrett wrote on behalf of the unanimous Court. In Bartenwerfer v.

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Court Constitutional Law Statute Court Decisions 52

FDA Law Blog

JUNE 2, 2023

Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices. Absent from the statute is any requirement to report information on manufacturer costs and price setting. that is not supported by the statute and applicable regulations.”

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Manufacturing Statute Government Calendaring 57

Constitutional Law Reporter

AUGUST 28, 2023

600 U.S. _ (2023), the U.S. Supreme Court upheld the constitutionality of state laws requiring corporations operating within their borders to consent to personal jurisdiction when they register to do business in those states. According to the Court, such laws do not offend the Constitution’s Due Process Clause. In Mallory v.

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Court Laws Cause of Action Constitutional Law 52

Constitutional Law Reporter

MAY 30, 2023

Supreme Court’s decision in Axon Enterprise, Inc. Federal Trade Commission , 598 U.S. _ (2023), allows federal district courts to consider constitutional challenges to administrative proceedings prior to the issuance of final rulings.

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Court Constitutional Law Entertainment Administrative Law 52

Conflict of Laws

FEBRUARY 22, 2024

The recent judgment of the High Court of Bahrain (a first instance court in the Bahraini judicial system ) in the Case No. 2/13276/2023/02 of 17 January 2024 is nothing but another example of this entrenched practice that can be observed in the vast majority of countries in the region. 5/11341/2023/02 of 4 January 2024 ).

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Court Laws Contract Court Decisions 69

At the Lectern

MAY 30, 2024

.’ ” The appellate court also found inapplicable the Legislature’s intent statement in newly enacted Assembly Bill 600 that, in resentencing proceedings under section 1172.1 , which the bill amended, “courts have full discretion. Agreeing with the Fourth District, Division One, decision in People v.

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Patently O

APRIL 12, 2023

The statute isclear that patents should be awarded to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” so long as the other requirements of patentability are met. One difficulty with the law here is that it is entirely judge made. SG Brief.

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Technology Manufacturing Court Statute 64

At the Lectern

AUGUST 6, 2024

Gregg and Seifu had been grant-and-holds in the California Supreme Court, which later dismissed review without opinions. Supreme Court the chance to disapprove the California Supreme Court decision in Adolph v. 2023) 14 Cal.5th Carry (2023) 15 Cal.5th Supreme Court also denied cert in Catarino v.

Technology 45

Technology Court Statute Court Decisions 45

Conflict of Laws

MAY 6, 2024

In the recent case of Ingang’a & 6 others v James Finlay (Kenya) Limited (Petition 7 (E009) of 2021) [2023] KESC 22 (KLR), the Kenyan Supreme Court dismissed an appeal for the recognition and enforcement of a locus inspection order issued by a Scottish Court. That procedure was not immediately apparent.

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Court Laws Statute Litigation 69

ClimateChange-ClimateLaw

APRIL 18, 2023

O n Monday, April 17, 2023, the U.S. Court of Appeals for the Ninth Circuit handed down a decision in California Restaurant Association v. The court overturned a District Court ruling to invalidate a Berkeley, California, prohibition on natural gas infrastructure in newly-constructed buildings. City of Berkeley.

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Construction Government Legal Legal 117

SCOTUSBlog

OCTOBER 5, 2023

Several of them are sequels to earlier high court decisions. First Amendment The current court is very solicitous of First Amendment rights. Oklahoma (resulting from Glossip’s fourth and fifth applications to that court for post-conviction relief), Glossip now seeks relief from the Supreme Court.

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Tort Court Litigation Litigating 119

Conflict of Laws

AUGUST 30, 2023

Final Update of 29 August 2023: New entries are printed bold. 1508-1545 (available here ) Casey, Alex “Holding out Hope for the Hague Judgments Project Thirty-Years Later: The Future of Express English Jurisdiction Clauses in Light of the London-Lugano Lacuna (Brexit, Brussels, and Beyond)”, Plassey Law Review 3 (2023), pp. 819 et seq.

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Drafting Laws Litigation Litigating 98

The Crime Report

SEPTEMBER 7, 2023

1994 to 2023 Prior to 1994, there were few states that required offenders convicted of sex offenses to register with local authorities—a registration that allows local law enforcement to monitor the location of sex offenders in their jurisdiction. In 1987, the trial court “set aside” the rape conviction through a “judicial clemency” order.

Statute 119

Statute Court Felony Attorney 119

At the Lectern

OCTOBER 11, 2023

It concluded “the Legislature passed this statute mainly with the intent of providing immunity for adverse pregnancy outcomes due to self-managed abortions or drug use during pregnancy.” The court granted review in People v. Schuller (2023) 15 Cal.5th ” Another ICWA grant-and-hold.

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Court Felony Statute Court Decisions 45

Constitutional Law Reporter

JULY 12, 2023

Texas , 599 U.S. _ (2023), the U.S. Supreme Court ruled that Texas and Louisiana lacked standing to challenge a Biden Administration immigration enforcement policy. In United States v. 1226(c) ) or entry of a final order of removal ( 8 U.S.C. 1231(a)(2) ).

Immigration 52

Immigration Court Rules Court Entertainment 52

Constitutional Law Reporter

AUGUST 2, 2023

Nebraska , 600 U.S. _ (2023), the U.S. Supreme Court struck down the Biden Administration’s student loan forgiveness program. Supreme Court’s Decision By a vote of 6-3, the Supreme Court agreed with the states that the HEROES Act does not authorize the loan cancellation plan. In Biden v.

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Court Education Drafting Legal 52

Constitutional Law Reporter

JULY 25, 2023

Elenis , 600 U.S. _ (2023), a divided U.S. Supreme Court held that the First Amendment prohibits Colorado from forcing a website designer to create expressive designs speaking messages with which the designer disagrees. In 303 Creative LLC v. to reserve from all official control.”

Court 52

Court Government Constitutional Law Statute 52

Conflict of Laws

AUGUST 31, 2022

In preparation of the Conference on the HCCH 2019 Judgments Convention on 9/10 June 2023, taking place on campus of the University of Bonn, Germany, we are offering here a Repository of contributions to the HCCH 2019 Judgments Convention. HCCH 2019 Judgments Convention Repository. Martiny, Dieter. Baden-Baden 2021, pp 127-146. “The

Drafting 40

Drafting Laws Litigation Litigating 40

Conflict of Laws

JUNE 21, 2022

In preparation of the Conference on the HCCH 2019 Judgments Convention on 9/10 June 2023 , taking place on campus of the University of Bonn, Germany, we are offering here a Repository of contributions to the HCCH 2019 Judgments Convention. HCCH 2019 Judgments Convention Repository. Martiny, Dieter. Baden-Baden 2021, pp 127-146. “The

Drafting 40

Drafting Laws Litigation Litigating 40

Conflict of Laws

SEPTEMBER 28, 2022

In preparation of the Conference on the HCCH 2019 Judgments Convention on 9/10 June 2023, taking place on campus of the University of Bonn, Germany, we are offering here a Repository of contributions to the HCCH 2019 Judgments Convention. HCCH 2019 Judgments Convention Repository. Martiny, Dieter. Baden-Baden 2021, pp 127-146. “The

Drafting 40

Drafting Laws Litigation Litigating 40

Conflict of Laws

APRIL 4, 2023

In preparation of the Conference on the HCCH 2019 Judgments Convention on 9/10 June 2023, taking place on campus of the University of Bonn, Germany, we are offering here a Repository of contributions to the HCCH 2019 Judgments Convention. Please also check the “official” Bibliography of the HCCH for the instrument. 8 (2021), pp. 819 et seq.

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Drafting Laws Litigation Litigating 52

Conflict of Laws

FEBRUARY 15, 2023

In preparation of the Conference on the HCCH 2019 Judgments Convention on 9/10 June 2023, taking place on campus of the University of Bonn, Germany, registration now open , we are offering here a Repository of contributions to the HCCH 2019 Judgments Convention. Please also check the “official” Bibliography of the HCCH for the instrument.

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Drafting Laws Litigation Litigating 40

SCOTUSBlog

FEBRUARY 23, 2023

But the court declined to invalidate the entire agency for this structural flaw, instead severing the for-cause provision from the rest of its authorizing statute. It argues that the 3rd Circuit’s decision has thrown all of that into upheaval and must be reviewed. New Relists Brown v. relisted after the Feb.

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Government Court Contract Malfeasance 86

Conflict of Laws

JUNE 7, 2023

Written by Christina Shin, University of Sydney Law School On 1 June 2023, International Children’s Day, the University of Sydney’s Centre for Asian and Pacific Law (CAPLUS) hosted an online webinar discussing the issue of children’s welfare and voices in private international law (PIL). 11 (such as returning a child post-abduction).

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Laws Family Law Legal Legal 40

ClimateChange-ClimateLaw

OCTOBER 20, 2020

1442, or the civil-rights removal statute, 28 U.S.C. The district court rejected eight grounds for removal, but the Fourth Circuit concluded its appellate jurisdiction was limited to determining whether the companies properly removed the case under the federal-officer removal statute. Mayor & City Council of Baltimore , No.

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Court Government Compensatory Damages Litigation 72