FDA Law Blog

APRIL 6, 2025

2, 2025) that affirms FDAs denial of authorization to market flavored vape products. To the manufacturers chagrin, FDA squarely rejected approximately 1.2 Frustrating as that may be for the manufacturers, FDAs denial orders did not constitute a change in existing policy. Wages & White Lion Investments, LLC , No.

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Manufacturing Court Court Decisions Litigation 59

SCOTUSBlog

OCTOBER 31, 2024

21) – Whether a manufacturer can file a petition for review in a circuit where it does not reside or have its principal place of business as long as it is joined by a seller of its products that is located within that circuit. Share The Supreme Court will hear an important First Amendment case on Jan. 13 and continues until Jan. Paxton (Jan.

Calendaring 119

Calendaring Manufacturing Court Laws 119

Conflict of Laws

MAY 9, 2025

23-1141 took place in March 2025 before the US Supreme Court. As previously indicated, this is a much-politicized case brought by Mexico against US gun manufacturers. The hearing before the US Supreme Court took place on 4 March 2025. Estados Unidos Mexicanos (Mexico) No. We have previously reported on this case here and here.

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Manufacturing Statute Court Punitive Damages 59

Patently O

FEBRUARY 13, 2025

As I wrote in an October 2024 post, this case raised fundamental questions about whether composition of matter claims could ever be considered abstract ideas simply because they included functional limitations or defined the composition through its properties rather than manufacturing steps. US Synthetic Corp. Int'l Trade Comm'n , No.

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Manufacturing Court 59

FDA Law Blog

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. The webinar will explore the legal and operational considerations for drug manufacturers.

Manufacturing 59

Manufacturing Legal Legal Government 59

FDA Law Blog

SEPTEMBER 11, 2024

Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens.

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Manufacturing 105

Patently O

MARCH 14, 2025

14, 2025) (Lourie, J.). This latest ruling stands in contrast to the court's January 2025 decisions upholding preliminary injunctions against Samsung Bioepis and Formycon, effectively blocking their biosimilar launches. Regeneron Pharms., Mylan Pharms. 2024-2351 (Fed.

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Manufacturing Litigation Litigating Court 45

FDA Law Blog

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.

Legal 59

Legal Legal Manufacturing Laws 59

Customs & International Trade Law

APRIL 17, 2025

national security of imports of pharmaceuticals and pharmaceutical ingredients and imports of semiconductors and semiconductor manufacturing equipment. Comments are due May 7, 2025. Department of Commerce Bureau of Industry and Security (BIS) announced the initiation of investigations into the effects on U.S.

Manufacturing 40

Manufacturing Drafting Government Laws 40

FDA Law Blog

MARCH 25, 2025

Within the Notification, FDA references a General Correspondence Letter (GCL) sent on February 26, 2025. FDA has recently issued an updated Notifications on Data Integrity Medical Devices.

Manufacturing 59

Manufacturing 59

FDA Law Blog

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. And it is exactly that!

Manufacturing 59

Manufacturing Legal Legal Laws 59

Mondaq

NOVEMBER 23, 2021

Selling web users' personal data is big business — with a projected worth of $400 billion by 2025. In industries as diverse as health insurance and automobile manufacturing.

Manufacturing 75

Manufacturing Court 75

Constitutional Law Reporter

DECEMBER 11, 2024

gun manufacturers. Estados Unidos Mexicanos , alleges the manufacturers aided and abetted the illegal sales of guns to traffickers for cartels in Mexico. gun manufacturers and one gun distributor. A decision is expected before the end of the term in June/July 2025. The suit, Smith & Wesson Brands v.

Manufacturing 98

Manufacturing Government Constitutional Law Court 98

Patently O

FEBRUARY 6, 2025

by Dennis Crouch The Federal Circuit has affirmed the PTAB finding of obviousness in an inter partes review (IPR) challenge to an integrated circuit manufacturing patent, even while disagreeing with the Board's claim construction. HD Silicon Solutions LLC v. Microchip Technology Inc. , 2023-1397 (Fed.

Construction 40

Construction Manufacturing Technology 40

FDA Law Blog

FEBRUARY 26, 2025

Trusting suppliers is still fundamental to any drug or device manufacturer. A 2025 study reported by Radical Compliance found that while senior management often believes in the robustness of their ethical culture, employees at other levels do not. Department of Justices Consumer Protection Branch.

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Diligence Manufacturing Statute Government 66

JURIST

JUNE 20, 2022

The manufacture and importation of single-use plastics will be banned in December 2022. Further, the Canadian Government “will also prohibit the export of [banned] plastics … by the end of 2025[.]” However, specific case exceptions will be included, including medically-necessary flexible straws.

Manufacturing 104

Manufacturing Government 104

Customs & International Trade Law

OCTOBER 25, 2024

Trade Representative announced certain modifications to the actions taken in the Section 301 investigation including a list of subheadings eligible for consideration of temporary exclusion under an exclusion process for certain machinery used in domestic manufacturing. The deadline for submitting exclusion requests is March 31, 2025.

Manufacturing 40

Manufacturing Technology Laws 40

JURIST

MAY 14, 2024

Besides maintaining the 2025 emissions reduction target of 15 percent for heavy trucks, the regulation also establishes new targets. The law called for a gradual reduction of the eco-innovation credits available to manufacturers and regular reports detailing progress toward these goals. The regulation proposes various objectives.

Manufacturing 118

Manufacturing Laws 118

FDA Law Blog

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Richardson has been promoted to Director. Kalie is the quintessential HPM lawyer.

Law Firms 59

Law Firms Law Firm Manufacturing Law School 59

Patently O

APRIL 21, 2025

by Dennis Crouch In a new decision released April 21, 2025, the Federal Circuit has given us another example of the jurisprudential divide between Judges Hughes and Reyna–something that I’ve followed across numerous opinions. the Commerce Department investigates whether foreign manufacturers are selling products in the U.S.

Construction 40

Construction Manufacturing Court Laws 40

Fordham Law News

OCTOBER 30, 2024

8] In his decision, Judge Mehta concluded that Google violated antitrust laws by striking exclusive agreements with device manufacturers such as Apple and Samsung. [9] 8] In his decision, Judge Mehta concluded that Google violated antitrust laws by striking exclusive agreements with device manufacturers such as Apple and Samsung. [9]

Manufacturing 52

Manufacturing Government Laws Technology 52

Above The Law

APRIL 22, 2025

What follows are Matthews answers to my remaining two questions as Newman Infinite prepares its appeal to the Peoples Supreme Court of China before April 30, 2025, seeking to overturn the remaining points of contention with respect to the lower courts infringement findings.

Litigating 76

Litigating Litigation Legal Legal 76

The Fashion Law

AUGUST 11, 2021

Gucci-owner Kering group, for example, has set a target to reduce greenhouse gas emissions by 50 percent by 2025. Meanwhile, LVMH used its perfume manufacturing facilities to make free hand sanitizer for the healthcare system in France.

Healthcare 143

Healthcare Manufacturing Laws 143

ClimateChange-ClimateLaw

MARCH 27, 2025

On March 18, 2025, Judge Ronnie Abrams dismissed the lawsuit with prejudice , penning an opinion that upholds Local Law 154 as a valid exercise of local authority beyond the purview of EPCAs preemption clause. In other words, EPCAs text and structure clearly intended to avoid a patchwork of conflicting and unpredictable regulations.

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Laws Court Construction Government 59

FDA Law Blog

NOVEMBER 16, 2021

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

Manufacturing 52

Manufacturing Government Entertainment Drafting 52

ClimateChange-ClimateLaw

OCTOBER 16, 2023

In 2025, that reduction in base credit will increase to 15 percent and in 2026, the base credit amount for direct pay claimants that cannot achieve the domestic content requirements will be reduced by 100 percent. If they can’t, they won’t be able to claim the ITC, even though it is notionally available until 2032.

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Government Manufacturing Finance Drafting 137

Conflict of Laws

APRIL 27, 2025

ur Tatlici, however, denies any involvement in the publications and maintains that the defamatory material was fabricated by Applicant Mehmet Tatlici and his Florida lawyers to manufacture a basis for litigation. [10] The Maltese Courts Decision In its judgment dated 13 February 2025 (Application No. 2025/720 Sor. [8]

Real Estate 49

Real Estate Legal Legal Court 49

Customs & International Trade Law

MARCH 26, 2025

MoCRA Requirements: FDA registration for cosmetics facilities Product listings for each cosmetic product Adverse event reporting Safety substantiation Compliance with Good Manufacturing Practices (GMPs) Fragrance allergen labeling MoCRA also gives the FDA new records access and mandatory recall authority.

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Manufacturing Laws 40

FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. issues with the design, manufacturing, and components of the device).

Manufacturing 64

Manufacturing Healthcare Education 64

FDA Law Blog

JULY 17, 2022

Under the new law, Part B will continue to pay for discarded amounts from single-dose containers, but the manufacturer must pay a rebate (called a “refund”) to Medicare for discarded amounts above a specified threshold. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

Manufacturing 52

Manufacturing Statute Government Laws 52

Customs & International Trade Law

MAY 22, 2025

On May 22, 2025, Colombia Forest Products, Commonwealth Plywood Co., Subsidy is defined by a foreign government providing financial assistance to a foreign company for manufacturing or exportation. Dumping occurs when a foreign company sells a product to the United States below its normal value or cost of production.

Manufacturing 40

Manufacturing Government Laws 40

Customs & International Trade Law

DECEMBER 26, 2024

Bureau of Industry and Security (BIS) BIS imposed a $180,000 mitigated penalty against Indium Corporation for 11 exports of electronics manufacturing components to Russia. Fruit juice manufacturing company and its former president plead guilty to food safety crimes. genetically modified corn exports violate the U.S.

Manufacturing 52

Manufacturing Drafting Government Laws 52

Strictly Business

FEBRUARY 29, 2024

For those reporting companies established or registered before January 1, 2024, the deadline for the initial BOI report is January 1, 2025. For more information about our services, please visit www.riggsdavie.com or contact our practice group by email at dealteam@riggsdavie.com.

Diligence 89

Diligence Calendaring Real Estate Business Services 89

The Fashion Law

AUGUST 9, 2021

Both Boohoo and Shein have garnered consumer pushback as a result of their labor exploitation, particularly given growing consumer awareness of – and demand for transparency when it comes to – the supply chain issues that are commonly tied to fast fashion, and other types of apparel manufacturing, as well. billion by the end of 2025.

Manufacturing 109

Manufacturing Contract Diligence Attorney 109

Customs & International Trade Law

JANUARY 10, 2025

What Food Manufacturers Should Do The rule is effective February 25, 2025, and the compliance date of the rule is February 25, 2028. In preparation for the compliance date, food manufacturers should review their products to ensure that any product that uses a healthy label meets the new criteria.

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Manufacturing Laws 40

FDA Law Blog

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). N/A June 30 The manufacturer must accept the price or counteroffer—with a rationale. CMS may respond to the counteroffer.

Manufacturing 45

Manufacturing Government Court 45

Customs & International Trade Law

MARCH 14, 2023

The exception to this is for textile, wool, and fur products as processing or manufacturing occurring in the U.S. billion by 2025, and at a CAGR of 6.8% The similarity in the rules is that neither Customs nor the FTC requires that goods made partially or wholly in the U.S. must be disclosed. billion to $604.34 to nearly $465.7

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Manufacturing Laws 74